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/NCT05985382</url>
    </required_header>
    <id_info>
      <org_study_id>5</org_study_id>
      <nct_id>NCT05985382</nct_id>
    </id_info>
    <brief_title>Comparing the Effects of Upper and Lower Body Resistance Training on Pain Sensitivity</brief_title>
    <official_title>Comparing the Effects of Upper and Lower Body Resistance Training on Pain Sensitivity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Central Florida</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Central Florida</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>
        Resistance exercise may immediately lessen the perception of pain. The purpose of this study&#xD;
        is compare the effects of an upper body exercise to a lower body exercise on the perception&#xD;
        of pain (pressure pain threshold).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">April 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 20, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heat Pain Threshold</measure>
      <time_frame>Heat pain threshold will be applied to the quadriceps, deltoid, and low back immediately before and immediately after each exercise (pre/post).</time_frame>
      <description>A thermode will gradually warm up from 32 degrees Celsius until the participant reports the sensation changes from comfortable warmth to slightly unpleasant pain. The temperature at threshold will be recorded.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pressure Pain Threshold</measure>
      <time_frame>Pressure pain threshold will be applied to the quadriceps, deltoid, and low back immediately before and immediately after each exercise (pre/post).</time_frame>
      <description>Pressure will be applied with a digital algometer. Pressure will be gradually increased until the participant reports the sensation changes from comfortable pressure to slightly unpleasant pain. The pressure at threshold will be recorded.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Lower Body Resistance Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will perform a leg extension exercise with weight that is 75% of their estimated 1-repetition maximum (1-RM) for 3 sets of 10 repetitions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Upper Body Resistance Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will perform a shoulder press with weight that is 75% of their estimated 1-repetition maximum (1-RM) for 3 sets of 10 repetitions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Lower Body Resistance Exercise</intervention_name>
      <description>Participants will complete a leg extension exercise with weight equivalent to 75% of their estimated 1-repetition maximum 3 sets, 10 repetitions.</description>
      <arm_group_label>Lower Body Resistance Exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Upper Body Resistance Exercise</intervention_name>
      <description>Participants will complete a leg extension exercise with weight equivalent to 75% of their estimated 1-repetition maximum 3 sets, 10 repetitions.</description>
      <arm_group_label>Upper Body Resistance Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  pain free&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  non-English speaking&#xD;
  &#xD;
            -  regular use of prescription pain medications&#xD;
  &#xD;
            -  current or history of chronic pain condition&#xD;
  &#xD;
            -  currently taking blood-thinning medication&#xD;
  &#xD;
            -  any blood clotting disorder&#xD;
  &#xD;
            -  medical conditions known to affect sensation, such as: uncontrolled diabetes or&#xD;
               neurological conditions&#xD;
  &#xD;
            -  any contraindication to the application of ice, including: uncontrolled hypertension,&#xD;
               cold urticaria, cryoglobulinemia, paroxysmal cold hemoglobinuria, circulatory&#xD;
               compromise&#xD;
  &#xD;
            -  not physically ready to exercise without a medical exam as indicated by the Physical&#xD;
               Activity Readiness Questionnaire Plus (PAR-Q+)&#xD;
  &#xD;
            -  surgery, injury, or fracture within the past 6 months&#xD;
  &#xD;
            -  unable to perform exercise portions of the study&#xD;
  &#xD;
            -  unable to attend three sessions&#xD;
  &#xD;
            -  pregnant&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abigail Wilson, PT, DPT, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Central Florida</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abigail Wilson, PT, DPT, PhD</last_name>
      <phone>4078231026</phone>
      <email>Abigail.Wilson@ucf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Central Florida</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32765</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abigail Wilson</last_name>
        <email>Abigail.Wilson@ucf.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Central Florida</investigator_affiliation>
      <investigator_full_name>Abigail Wilson</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypersensitivity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05985382
  org study id: 5
  nct id: NCT05985382
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Resistance exercise may immediately lessen the perception of pain. The purpose of this study
        is compare the effects of an upper body exercise to a lower body exercise on the perception
        of pain (pressure pain threshold).
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Heat Pain Threshold
  time frame: Heat pain threshold will be applied to the quadriceps, deltoid, and low back immediately before and immediately after each exercise (pre/post).
  description: A thermode will gradually warm up from 32 degrees Celsius until the participant reports the sensation changes from comfortable warmth to slightly unpleasant pain. The temperature at threshold will be recorded.
  measure: Pressure Pain Threshold
  time frame: Pressure pain threshold will be applied to the quadriceps, deltoid, and low back immediately before and immediately after each exercise (pre/post).
  description: Pressure will be applied with a digital algometer. Pressure will be gradually increased until the participant reports the sensation changes from comfortable pressure to slightly unpleasant pain. The pressure at threshold will be recorded.
  arm group label: Lower Body Resistance Exercise
  arm group type: Experimental
  description: Participants will perform a leg extension exercise with weight that is 75% of their estimated 1-repetition maximum (1-RM) for 3 sets of 10 repetitions.
  arm group label: Upper Body Resistance Exercise
  arm group type: Experimental
  description: Participants will perform a shoulder press with weight that is 75% of their estimated 1-repetition maximum (1-RM) for 3 sets of 10 repetitions.
  intervention type: Other
  intervention name: Lower Body Resistance Exercise
  description: Participants will complete a leg extension exercise with weight equivalent to 75% of their estimated 1-repetition maximum 3 sets, 10 repetitions.
  arm group label: Lower Body Resistance Exercise
  intervention type: Other
  intervention name: Upper Body Resistance Exercise
  description: Participants will complete a leg extension exercise with weight equivalent to 75% of their estimated 1-repetition maximum 3 sets, 10 repetitions.
  arm group label: Upper Body Resistance Exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Abigail Wilson, PT, DPT, PhD
  role: Principal Investigator
  affiliation: University of Central Florida
  last name: Abigail Wilson, PT, DPT, PhD
  phone: 4078231026
  email: Abigail.Wilson@ucf.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Central Florida
  investigator full name: Abigail Wilson
  investigator title: Assistant Professor
  mesh term: Hypersensitivity
  sharing ipd: Undecided