<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/NCT03753295</url>
  </required_header>
  <id_info>
    <org_study_id>27704112500</org_study_id>
    <nct_id>NCT03753295</nct_id>
  </id_info>
  <brief_title>The Effect of BMI on Hand Grip Force in Healthy Adults</brief_title>
  <official_title>The Effect of BMI on Hand Grip Force in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wafaa Mahmoud Amin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Jazan</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>
      This study will be conducted to investigate the effect of BMI on hand grip force in healthy&#xD;
      subjects. The participants in this study will be 90 healthy subjects with right dominant&#xD;
      lower limb (49 females and 49 males) they will be recruited from College of Applied Medical&#xD;
      Sciences, Jazan University.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will be categorized according to BMI into three groups:&#xD;
&#xD;
      Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI&lt;25&#xD;
      kg/m2) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with&#xD;
      (BMI, 25-30 kg/m2).&#xD;
&#xD;
      Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI&gt;30 kg/m2).&#xD;
&#xD;
      Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New&#xD;
      York, USA) will be used to measure the hand grip strength and pinch strength&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2, 2018</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 3, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hand Grip Force of the Right Dominant Hand in The Three Groups</measure>
    <time_frame>10 minutes</time_frame>
    <description>Hand Grip strength will be measured in three groups and comparison between them will be made</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of Hand Grip Force between Both Arms in three Groups</measure>
    <time_frame>20 minutes</time_frame>
    <description>Measurement of both right dominant hand and left hand will be measured in the three groups and compared with each other.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the effect of gender on the hand grip</measure>
    <time_frame>10 minutes</time_frame>
    <description>measurement of hand grip force of the right dominant hand will be taken for both male and females in the three subjects</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Motor Activity</condition>
  <condition>Overweight and Obesity</condition>
  <condition>Hand Injuries</condition>
  <arm_group>
    <arm_group_label>Group I (normal subjects)</arm_group_label>
    <description>30 individuals (15 male, and 15 female students) with (BMI&lt;25 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (overweight subjects)</arm_group_label>
    <description>30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III (obese subjects)</arm_group_label>
    <description>30 individuals (15 male, and 15 female students) (BMI&gt;30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hand Grip Force</intervention_name>
    <description>For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.&#xD;
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.&#xD;
The test will be performed twice, and the higher value between the two measurements will be selected.&#xD;
The subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress</description>
    <arm_group_label>Group I (normal subjects)</arm_group_label>
    <arm_group_label>Group II (overweight subjects)</arm_group_label>
    <arm_group_label>Group III (obese subjects)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        90 healthy male and female students with age 19 to 25 years old, and right dominant hand,&#xD;
        will be recruited from the College of Applied Medical Sciences, Jazan University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects would not have any diseases of the central nervous system.&#xD;
&#xD;
          2. Subjects would not have any orthopedic disorders either of the trunk or the lower&#xD;
             limbs in the previous year.&#xD;
&#xD;
          3. None of the subjects has history of balance training ( Erkmen et al., 2010, Li Li,&#xD;
             2012) .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Sign of foot pain, reduced tactile and thermal foot sensibility.&#xD;
&#xD;
          2. Peripheral neuropathy.&#xD;
&#xD;
          3. A history of previous back or abdominal surgery/injury&#xD;
&#xD;
          4. A history of patellofemoral pain syndrome, plantar fasciitis, and back pain .&#xD;
&#xD;
          5. Limb-length discrepancy, and anterior or posterior tibialis dysfunction.&#xD;
&#xD;
          6. Evidence of a systemic or musculoskeletal disease within the past six months&#xD;
             (AlAbdulwahab &amp; Kachanathu, 2016).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Jazan University</name>
      <address>
        <city>Riyadh</city>
        <state>Jazan</state>
        <zip>45142</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>March 10, 2019</last_update_submitted>
  <last_update_submitted_qc>March 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jazan</investigator_affiliation>
    <investigator_full_name>Wafaa Mahmoud Amin</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>BMI, Hand Grip, Healthy Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Hand Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03753295
org study id: 27704112500
nct id: NCT03753295
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to investigate the effect of BMI on hand grip force in healthy
      subjects. The participants in this study will be 90 healthy subjects with right dominant
      lower limb (49 females and 49 males) they will be recruited from College of Applied Medical
      Sciences, Jazan University.
Subjects will be categorized according to BMI into three groups:

      Group I (normal subjects): 30 individuals (15 male, and 15 female students) with (BMI<25
      kg/m2) Group II (overweight subjects): 30 individuals (15 male, and 15 female students) with
      (BMI, 25-30 kg/m2).

      Group III (obese subjects): 30 individuals (15 male, and 15 female students) (BMI>30 kg/m2).

      Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New
      York, USA) will be used to measure the hand grip strength and pinch strength
observational model: Case-Control
time perspective: Retrospective
measure: Hand Grip Force of the Right Dominant Hand in The Three Groups
time frame: 10 minutes
description: Hand Grip strength will be measured in three groups and comparison between them will be made
measure: Comparison of Hand Grip Force between Both Arms in three Groups
time frame: 20 minutes
description: Measurement of both right dominant hand and left hand will be measured in the three groups and compared with each other.
measure: the effect of gender on the hand grip
time frame: 10 minutes
description: measurement of hand grip force of the right dominant hand will be taken for both male and females in the three subjects
arm group label: Group I (normal subjects)
description: 30 individuals (15 male, and 15 female students) with (BMI<25 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.
arm group label: Group II (overweight subjects)
description: 30 individuals (15 male, and 15 female students) with (BMI, 25-30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.
arm group label: Group III (obese subjects)
description: 30 individuals (15 male, and 15 female students) (BMI>30 kg/m2). Hand grip force will measured using Baseline Hydraulic Hand Dynamometer.
intervention type: Diagnostic Test
intervention name: Hand Grip Force
description: For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.
The test will be performed twice, and the higher value between the two measurements will be selected.
The subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress
arm group label: Group I (normal subjects)
arm group label: Group II (overweight subjects)
arm group label: Group III (obese subjects)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 25 Years
facility: 
country: Saudi Arabia
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jazan
investigator full name: Wafaa Mahmoud Amin
investigator title: Lecturer
mesh term: Overweight
mesh term: Hand Injuries
sharing ipd: Undecided