xml: <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/NCT06012422</url>
    </required_header>
    <id_info>
      <org_study_id>KU-FTR-SA-01</org_study_id>
      <nct_id>NCT06012422</nct_id>
    </id_info>
    <brief_title>Sarcopenia Screening in Elderly Individuals</brief_title>
    <official_title>Sarcopenia Screening in Elderly Individuals Living in Kirikkale Province</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kırıkkale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kırıkkale University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass&#xD;
        measurement, loss of strength that may develop due to sarcopenia, loss of balance and related&#xD;
        fall, decrease in functionality, fragility and decreased physical activity in individuals&#xD;
        aged 65 years and older in Kırıkkale city center.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Although aging occurs in all periods in the human body, physical, mental and physical aging&#xD;
        becomes visible as you get older. This situation is caused by physiological aging,&#xD;
        environmental factors, existing chronic diseases and related symptoms. Today, increasing life&#xD;
        expectancy and aging population must be taken into account. Since the age-related symptoms of&#xD;
        elderly individuals are compatible with the consequences of aging, they can be ignored as a&#xD;
        natural process, and therefore its progression cannot be prevented. With our project, it is&#xD;
        aimed that screening for sarcopenia will be an exemplary study throughout Turkey and this&#xD;
        type of screening will be widespread. In addition, it is aimed to divide elderly individuals&#xD;
        into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary&#xD;
        guidance, protective and prevention approaches, strengthening and exercise training.&#xD;
  &#xD;
        Demographic data of elderly individuals (age, gender, height, weight, BMI (Body mass index&#xD;
        will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic&#xD;
        diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (COPD), rheumatic&#xD;
        diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'Clinical&#xD;
        Vulnerability Scale' to evaluate the cognitive status of individuals through the 'Mini&#xD;
        Nutritional Assessment form (MNA)'. 'Standardized Mini-Mental Test' to assess balance and&#xD;
        walking, 'Tinetti balance and walking test' to evaluate balance and walking, 'Falling Risk&#xD;
        Self-Assessment Scale' to assess falls, 'Functional Independence and Challenge Scale' to&#xD;
        measure functional independence in activities of daily living. 'Short Physical Performance&#xD;
        Test' (KFPT), Sarcopenia screening test (SA) to assess physical fitness RC-F), it is planned&#xD;
        to use the Physical Activity Scale for the Elderly (PASE) to evaluate the level of physical&#xD;
        activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle&#xD;
        mass of individuals with an inbody bioimpedance device.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>There is no randomization in our study, all elderly individuals who meet the inclusion and exclusion criteria will be evaluated.</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bioimpedance Analysis</measure>
      <time_frame>day 1</time_frame>
      <description>used to measure muscle mass in epidemiological studies.A muscle mass index of less than 5.5 in women and less than 7 in men is associated with the risk of sarcopenia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Muscle Strength Evaluation</measure>
      <time_frame>day 1</time_frame>
      <description>Handgrip strength is more commonly used, and low handgrip strength correlates better with impaired mobility and undesirable clinical outcomes than low muscle mass. In practice, a linear relationship was also found between basal handshake strength and dependence on activities of daily living. Therefore, hand grip strength measurement is a good and simple method to evaluate muscle strength.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short Physical Performance Test</measure>
      <time_frame>day 1</time_frame>
      <description>The test measures parameters such as balance, sitting and standing from a chair and walking speed.All three physical performance measures (walking speed, balance, getting up from a chair) are scored between 0-4 according to the duration of the activity, the scores of the three tests are summed to give a total score between 0 (poor) and 12 (very good).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SARC-F</measure>
      <time_frame>day 1</time_frame>
      <description>Used for rapid diagnosis of sarcopenia.In the SARC-F questionnaire, information such as strength, walking without support, getting up from a chair/stool, climbing stairs and the number of falls in the last year are questioned (66). According to the EWGSOP2 guideline, a score of 4 or higher on the SARC-F questionnaire is considered significant in terms of sarcopenia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini Nutritional Assessment</measure>
      <time_frame>day 1</time_frame>
      <description>The long MNA contains 18 items collected in 4 chapters. These four parts; anthropometric assessment (BMI, weight, arm and calf circumferences); overall assessment (lifestyle, medication, mobility, depression and dementia symptoms); short nutritional assessment (number of meals, food and fluid intake, autonomy in nutrition) and subjective assessment (self-perception of health and nutrition)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Activity Scale for the Elderly</measure>
      <time_frame>day 1</time_frame>
      <description>The questionnaire evaluates the physical activities of the bereaved individuals in the last week and includes the components of leisure time, housework and work-related physical activity. walking activity outside the home; mild, moderate and vigorous sports and recreational activities; Participation in leisure time activities, including muscle strengthening exercises, was recorded as never, rarely (1-2 days / week), sometimes (3-4 days / week), and often (5-7 days / week), while the duration of the activities was: 1 It is classified as less than 1 hour, 1-2 hours, 2-4 hours and more than 4 hours.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tinetti balance and walking test</measure>
      <time_frame>day 1</time_frame>
      <description>assesses balance and walking.In the test, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points, and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the risk of falling increases as the score decreases.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fall Risk Self-Assessment Scale</measure>
      <time_frame>day 1</time_frame>
      <description>It is a scale that assesses the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who get 4 points or more from the score are classified as having a high risk of falling.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anthropometric Measurements</measure>
      <time_frame>day 1</time_frame>
      <description>Anthropometric measurements of middle arm muscle circumference and calf circumference have been shown to predict functionality, general health status, nutritional adequacy, and survival in the elderly.&#xD;
  It has been reported that calf circumference of 31 cm or less, arm circumference of 23 cm or less in women, and 24 cm or less in men are associated with sarcopenia.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">843</enrollment>
    <condition>Sarcopenia</condition>
    <arm_group>
      <arm_group_label>Individuals aged 65 and over who were screened for sarcopenia</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Persons aged 65 and over will be evaluated only once and the assessment will be made through a face-to-face interview.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>evaluation group</intervention_name>
      <description>Elderly individuals will be evaluated once, by face-to-face interview method.</description>
      <arm_group_label>Individuals aged 65 and over who were screened for sarcopenia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Individuals aged 65 and over&#xD;
  &#xD;
            -  Their willingness to participate in the study&#xD;
  &#xD;
            -  A score of 24 or higher on the Mini Mental State Test (MMDT)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals under the age of 65&#xD;
  &#xD;
            -  Individuals who cannot communicate well&#xD;
  &#xD;
            -  Elderly individuals who cannot walk independently, have any orthopedic or neurological&#xD;
               problems&#xD;
  &#xD;
            -  Individuals who do not want to participate in the study&#xD;
  &#xD;
            -  Individuals not eligible for bioimpedance analysis (pregnant individuals with&#xD;
               pacemakers).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kırıkkale University</investigator_affiliation>
      <investigator_full_name>Seyma Akdagli</investigator_full_name>
      <investigator_title>Master of Science Student</investigator_title>
    </responsible_party>
    <keyword>rehabilitation</keyword>
    <keyword>physical inactivity</keyword>
    <keyword>fragility</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>
  
  
text: 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/NCT06012422
  org study id: KU-FTR-SA-01
  nct id: NCT06012422
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  In this study, it is aimed to evaluate parameters such as sarcopenia screening, muscle mass
        measurement, loss of strength that may develop due to sarcopenia, loss of balance and related
        fall, decrease in functionality, fragility and decreased physical activity in individuals
        aged 65 years and older in Kırıkkale city center.
  Although aging occurs in all periods in the human body, physical, mental and physical aging
        becomes visible as you get older. This situation is caused by physiological aging,
        environmental factors, existing chronic diseases and related symptoms. Today, increasing life
        expectancy and aging population must be taken into account. Since the age-related symptoms of
        elderly individuals are compatible with the consequences of aging, they can be ignored as a
        natural process, and therefore its progression cannot be prevented. With our project, it is
        aimed that screening for sarcopenia will be an exemplary study throughout Turkey and this
        type of screening will be widespread. In addition, it is aimed to divide elderly individuals
        into groups as presarcopenia, sarcopenia and severe sarcopenia, and to provide necessary
        guidance, protective and prevention approaches, strengthening and exercise training.
  
        Demographic data of elderly individuals (age, gender, height, weight, BMI (Body mass index
        will be obtained by dividing body weight (kg), height (m) squared) occupation, etc.), chronic
        diseases (hypertension, diabetes, chronic obstructive pulmonary disease) (COPD), rheumatic
        diseases), drugs used, smoking, alcohol habits, and assistive device use, and the 'Clinical
        Vulnerability Scale' to evaluate the cognitive status of individuals through the 'Mini
        Nutritional Assessment form (MNA)'. 'Standardized Mini-Mental Test' to assess balance and
        walking, 'Tinetti balance and walking test' to evaluate balance and walking, 'Falling Risk
        Self-Assessment Scale' to assess falls, 'Functional Independence and Challenge Scale' to
        measure functional independence in activities of daily living. 'Short Physical Performance
        Test' (KFPT), Sarcopenia screening test (SA) to assess physical fitness RC-F), it is planned
        to use the Physical Activity Scale for the Elderly (PASE) to evaluate the level of physical
        activity, to use hand dynamometer, to evaluate muscle strength, and to measure the muscle
        mass of individuals with an inbody bioimpedance device.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: There is no randomization in our study, all elderly individuals who meet the inclusion and exclusion criteria will be evaluated.
  primary purpose: Screening
  masking: None (Open Label)
  measure: Bioimpedance Analysis
  time frame: day 1
  description: used to measure muscle mass in epidemiological studies.A muscle mass index of less than 5.5 in women and less than 7 in men is associated with the risk of sarcopenia.
  measure: Muscle Strength Evaluation
  time frame: day 1
  description: Handgrip strength is more commonly used, and low handgrip strength correlates better with impaired mobility and undesirable clinical outcomes than low muscle mass. In practice, a linear relationship was also found between basal handshake strength and dependence on activities of daily living. Therefore, hand grip strength measurement is a good and simple method to evaluate muscle strength.
  measure: Short Physical Performance Test
  time frame: day 1
  description: The test measures parameters such as balance, sitting and standing from a chair and walking speed.All three physical performance measures (walking speed, balance, getting up from a chair) are scored between 0-4 according to the duration of the activity, the scores of the three tests are summed to give a total score between 0 (poor) and 12 (very good).
  measure: SARC-F
  time frame: day 1
  description: Used for rapid diagnosis of sarcopenia.In the SARC-F questionnaire, information such as strength, walking without support, getting up from a chair/stool, climbing stairs and the number of falls in the last year are questioned (66). According to the EWGSOP2 guideline, a score of 4 or higher on the SARC-F questionnaire is considered significant in terms of sarcopenia.
  measure: Mini Nutritional Assessment
  time frame: day 1
  description: The long MNA contains 18 items collected in 4 chapters. These four parts; anthropometric assessment (BMI, weight, arm and calf circumferences); overall assessment (lifestyle, medication, mobility, depression and dementia symptoms); short nutritional assessment (number of meals, food and fluid intake, autonomy in nutrition) and subjective assessment (self-perception of health and nutrition)
  measure: Physical Activity Scale for the Elderly
  time frame: day 1
  description: The questionnaire evaluates the physical activities of the bereaved individuals in the last week and includes the components of leisure time, housework and work-related physical activity. walking activity outside the home; mild, moderate and vigorous sports and recreational activities; Participation in leisure time activities, including muscle strengthening exercises, was recorded as never, rarely (1-2 days / week), sometimes (3-4 days / week), and often (5-7 days / week), while the duration of the activities was: 1 It is classified as less than 1 hour, 1-2 hours, 2-4 hours and more than 4 hours.
  measure: Tinetti balance and walking test
  time frame: day 1
  description: assesses balance and walking.In the test, the walking score is a maximum of 12 points, the balance score is a maximum of 16 points, and a total of 28 points. Those who score twenty-six and below are considered to have a problem. Studies have shown that the risk of falling increases as the score decreases.
  measure: Fall Risk Self-Assessment Scale
  time frame: day 1
  description: It is a scale that assesses the risk of falling in the elderly. It consists of 13 items assessing the risk of falling in the elderly. The answers are yes (1 point) and no (0 points), and individuals who get 4 points or more from the score are classified as having a high risk of falling.
  measure: Anthropometric Measurements
  time frame: day 1
  description: Anthropometric measurements of middle arm muscle circumference and calf circumference have been shown to predict functionality, general health status, nutritional adequacy, and survival in the elderly.
  It has been reported that calf circumference of 31 cm or less, arm circumference of 23 cm or less in women, and 24 cm or less in men are associated with sarcopenia.
  arm group label: Individuals aged 65 and over who were screened for sarcopenia
  arm group type: Other
  description: Persons aged 65 and over will be evaluated only once and the assessment will be made through a face-to-face interview.
  intervention type: Other
  intervention name: evaluation group
  description: Elderly individuals will be evaluated once, by face-to-face interview method.
  arm group label: Individuals aged 65 and over who were screened for sarcopenia
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Kırıkkale University
  investigator full name: Seyma Akdagli
  investigator title: Master of Science Student
  mesh term: Sarcopenia