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/NCT06015438</url>
    </required_header>
    <id_info>
      <org_study_id>20230495</org_study_id>
      <nct_id>NCT06015438</nct_id>
    </id_info>
    <brief_title>Physical Activity in Hidradenitis Suppurativa (HS)</brief_title>
    <official_title>Physical Activity and Hidradenitis Suppurativa: A Novel Controlled Trial Investigating Functional Performance and Activity Limitations and Assessing the Benefits of an Outcome Measures Driven Exercise Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</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 purpose of the study is to characterize the challenges to physical activity and exercise&#xD;
        for HS patients and design an exercise program (EP) with evidence-based techniques and&#xD;
        examine its outcome.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Functional Strength/Endurance as Measured by 30-second chair-stand test</measure>
      <time_frame>Baseline and up to 12 weeks</time_frame>
      <description>Determines how many times a person can rise from a chair and sit down again in 30 seconds while keeping their arms crossed over their chest. The test will assess lower body strength and endurance and will be reported using a composite score of the number of times completed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Functional Strength/Endurance as measured by six-minute walk test</measure>
      <time_frame>Baseline and up to 12 weeks</time_frame>
      <description>Six-minute walk measures overall functioning capacity, and lower body muscle strength/ endurance, with a composite score reported in meters.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in Functional Strength as measured by hand grip strength test</measure>
      <time_frame>Baseline and up to 12 weeks</time_frame>
      <description>It is a measure of upper body muscular strength measured in kilograms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quality of life impairment as measured by the DLQI</measure>
      <time_frame>Baseline, up to 12 weeks</time_frame>
      <description>Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life impairment as measured by the HiSQOL</measure>
      <time_frame>Baseline, up to 12 weeks</time_frame>
      <description>Hidradenitis Suppurativa Quality of Life (HiSQOL) has a total score ranging from 0 to 68 with the lower score indicating higher health related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)</measure>
      <time_frame>Baseline, up to 12 weeks</time_frame>
      <description>IPAQ assesses 3 types of physical activity undertaken across the 4 domains- leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity- in the previous 7 days. The 3 types of activity assessed are walking, moderate-intensity activities and vigorous-intensity activities. The result s is not reported in scales. Computation of the total score for the IPAQ requires summation of the duration (in minutes) and frequency (days) of the 3 types of activities across the 4 domains. Higher result indicates higher physical activity in the last 7 days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Level of Activity as measured by the average number of steps daily</measure>
      <time_frame>Baseline, up to 12 weeks</time_frame>
      <description>Average number of steps daily will be measured with a pedometer and will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Severity of HS score using the IHS-4</measure>
      <time_frame>Baseline, up to 12 weeks</time_frame>
      <description>The International Hidradenitis Suppurativa Severity Score System (IHS4) measures HS severity as mild (0-3), moderate (4-10), severe (≥11). Higher score indicate increased severity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average pain as assessed by the Numerical Rating Scale (NRS)</measure>
      <time_frame>Up to 8 weeks</time_frame>
      <description>The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hidradenitis Suppurativa</condition>
    <arm_group>
      <arm_group_label>Home Exercise EP Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will follow an at home personalized EP for up to 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Short EP Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants in this group will be enrolled in the short EP program.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Home Exercise Program</intervention_name>
      <description>Participants will perform a minimum of one exercise from each of the targeted muscle groups at a frequency of every other day, for a total of 3-4 days a week of exercise with a rest day. The entire strengthening exercise routine should take approximately 25-30 minutes to perform, including rest periods. Each muscle grouping of exercises is designed to progress from minimal muscle effort required to moderate to maximal effort. Participants will use a video to perform the exercises as well as a handout with specific instructions.</description>
      <arm_group_label>Home Exercise EP Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Short Exercise Program</intervention_name>
      <description>Participants in this group will attend one in-person visit expected to last about 60 minutes. The clinic visit will consist of standard of care procedures and tests for individuals with mild-to-severe HS .</description>
      <arm_group_label>Short EP Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults 18 years old to 80 years old&#xD;
  &#xD;
            -  Have diagnosis of HS confirmed by a dermatologist&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
            -  For the extended portion of the study: Classified as having moderate-to-severe HS as&#xD;
               per the IHS-4 criteria&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals who are not yet adults&#xD;
  &#xD;
            -  Women known to be pregnant&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Subjects, who in the opinion of the PI, cannot comply with the study procedures&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hadar Lev-Tov, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hadar V Lev-Tov, MD</last_name>
      <phone>3052431953</phone>
      <email>hlevtov@med.miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Miami</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33125</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria V Muniz</last_name>
        <phone>305-689-2646</phone>
        <email>mmuniz@med.miami.edu</email>
      </contact>
      <contact_backup>
        <last_name>Leigh Nattkemper, MD</last_name>
        <phone>3055889734</phone>
        <email>lxn202@med.miami.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Hadar Lev-Tov, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Hadar Lev-Tov</investigator_full_name>
      <investigator_title>Associate Professor of Clinical</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hidradenitis Suppurativa</mesh_term>
      <mesh_term>Hidradenitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06015438
  org study id: 20230495
  nct id: NCT06015438
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to characterize the challenges to physical activity and exercise
        for HS patients and design an exercise program (EP) with evidence-based techniques and
        examine its outcome.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in Functional Strength/Endurance as Measured by 30-second chair-stand test
  time frame: Baseline and up to 12 weeks
  description: Determines how many times a person can rise from a chair and sit down again in 30 seconds while keeping their arms crossed over their chest. The test will assess lower body strength and endurance and will be reported using a composite score of the number of times completed.
  measure: Change in Functional Strength/Endurance as measured by six-minute walk test
  time frame: Baseline and up to 12 weeks
  description: Six-minute walk measures overall functioning capacity, and lower body muscle strength/ endurance, with a composite score reported in meters.
  measure: Change in Functional Strength as measured by hand grip strength test
  time frame: Baseline and up to 12 weeks
  description: It is a measure of upper body muscular strength measured in kilograms.
  measure: Quality of life impairment as measured by the DLQI
  time frame: Baseline, up to 12 weeks
  description: Dermatology Life Quality Index (DLQI) has a total score ranging from 0 to 30 with the lower score indicating higher health related quality of life.
  measure: Quality of life impairment as measured by the HiSQOL
  time frame: Baseline, up to 12 weeks
  description: Hidradenitis Suppurativa Quality of Life (HiSQOL) has a total score ranging from 0 to 68 with the lower score indicating higher health related quality of life.
  measure: Change in Physical activity as measured by the International Physical Activity Questionnaire (IPAQ)
  time frame: Baseline, up to 12 weeks
  description: IPAQ assesses 3 types of physical activity undertaken across the 4 domains- leisure time physical activity; domestic and gardening (yard) activities; work-related physical activity; transport-related physical activity- in the previous 7 days. The 3 types of activity assessed are walking, moderate-intensity activities and vigorous-intensity activities. The result s is not reported in scales. Computation of the total score for the IPAQ requires summation of the duration (in minutes) and frequency (days) of the 3 types of activities across the 4 domains. Higher result indicates higher physical activity in the last 7 days
  measure: Change in Level of Activity as measured by the average number of steps daily
  time frame: Baseline, up to 12 weeks
  description: Average number of steps daily will be measured with a pedometer and will be reported.
  measure: Change in Severity of HS score using the IHS-4
  time frame: Baseline, up to 12 weeks
  description: The International Hidradenitis Suppurativa Severity Score System (IHS4) measures HS severity as mild (0-3), moderate (4-10), severe (≥11). Higher score indicate increased severity.
  measure: Average pain as assessed by the Numerical Rating Scale (NRS)
  time frame: Up to 8 weeks
  description: The average pain will be measured using the NRS with scores ranging from 0-10 with the higher score indicating more severe pain.
  arm group label: Home Exercise EP Group
  arm group type: Experimental
  description: Participants in this group will follow an at home personalized EP for up to 12 weeks.
  arm group label: Short EP Group
  arm group type: Active Comparator
  description: Participants in this group will be enrolled in the short EP program.
  intervention type: Behavioral
  intervention name: Home Exercise Program
  description: Participants will perform a minimum of one exercise from each of the targeted muscle groups at a frequency of every other day, for a total of 3-4 days a week of exercise with a rest day. The entire strengthening exercise routine should take approximately 25-30 minutes to perform, including rest periods. Each muscle grouping of exercises is designed to progress from minimal muscle effort required to moderate to maximal effort. Participants will use a video to perform the exercises as well as a handout with specific instructions.
  arm group label: Home Exercise EP Group
  intervention type: Behavioral
  intervention name: Short Exercise Program
  description: Participants in this group will attend one in-person visit expected to last about 60 minutes. The clinic visit will consist of standard of care procedures and tests for individuals with mild-to-severe HS .
  arm group label: Short EP Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hadar Lev-Tov, MD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Hadar V Lev-Tov, MD
  phone: 3052431953
  email: hlevtov@med.miami.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Hadar Lev-Tov
  investigator title: Associate Professor of Clinical
  mesh term: Hidradenitis Suppurativa
  mesh term: Hidradenitis
  sharing ipd: No