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/NCT06039488</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00109975</org_study_id>
      <nct_id>NCT06039488</nct_id>
    </id_info>
    <brief_title>Effectiveness of a Cancer Exercise Program</brief_title>
    <official_title>The Impact of an 8-week Exercise Program on Physical Function in Individuals With Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of South Carolina</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>
        The investigators are examining the impact of an 8-week multi-modal exercise program&#xD;
        (resistance and cardiovascular training) delivered 2 times per week on physical function&#xD;
        adults (&gt;18 years old) with cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 15, 2021</start_date>
    <completion_date type="Anticipated">January 2027</completion_date>
    <primary_completion_date type="Anticipated">January 2026</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bellarmine Norton Assessment Tool (2-minute Step Test)</measure>
      <time_frame>0 and 8-weeks</time_frame>
      <description>2-minute Step Test: Number of times an individuals' knee reaches a predetermined heigh during a 2-minute period of marching</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bellarmine Norton Assessment Tool (Timed Arm Curl)</measure>
      <time_frame>0 and 8-weeks</time_frame>
      <description>Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bellarmine Norton Assessment Tool (30 second Chair Stand)</measure>
      <time_frame>0 and 8-weeks</time_frame>
      <description>Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Fatigue</measure>
      <time_frame>0 and 8-weeks</time_frame>
      <description>The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: The FACIT-Fatigue scale is a 13-item scale that will be used to assess cancer-related fatigue. The FACIT-Fatigue scale is scored on a 0-4 response scale from 0 = &quot;not at all&quot; to 4 &quot;very much&quot;, regarding items related to fatigue and energy in the past 7 days. Lower score indicates greater fatigue</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>2 days/week of resistance and cardiovascular exercise for 8-weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exercise</intervention_name>
      <description>A combination of resistance exercise and cardiovascular exercise (performed 2 days per week for 8-weeks) is tailored to each individual in accordance with their medical/cancer-related history, baseline assessments of physical function, and overall goals.&#xD;
  Resistance exercise includes 6-8 exercises targeting major muscle groups. The first week of the program is used to familiarize participants to the exercises of the program, provide coaching on safe and appropriate technique, and identifying initial load for 2 sets of 12 repetitions (equivalent to ~65% 1 repetition maximum), with a goal of working towards 4 sets of 8 reps. Additionally, participants are asked to perform 20-30 minutes of moderate-to-vigorous aerobic activity (approximately 60-85% age-predicted heart rate maximum) via walking, jogging, or cycling each session.</description>
      <arm_group_label>Exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults &gt; 18 diagnosed with cancer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unwilling to come to the on-site clinic for exercise sessions&#xD;
  &#xD;
            -  any neuromuscular, cardiovascular, or psychological condition precluding safe exercise&#xD;
  &#xD;
            -  unable to read/understand English.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of South Carolina</name>
        <address>
          <city>Columbia</city>
          <state>South Carolina</state>
          <zip>29205</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of South Carolina</investigator_affiliation>
      <investigator_full_name>Ciaran Fairman</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Exercise</keyword>
    <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/NCT06039488
  org study id: Pro00109975
  nct id: NCT06039488
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The investigators are examining the impact of an 8-week multi-modal exercise program
        (resistance and cardiovascular training) delivered 2 times per week on physical function
        adults (>18 years old) with cancer.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Bellarmine Norton Assessment Tool (2-minute Step Test)
  time frame: 0 and 8-weeks
  description: 2-minute Step Test: Number of times an individuals' knee reaches a predetermined heigh during a 2-minute period of marching
  measure: Bellarmine Norton Assessment Tool (Timed Arm Curl)
  time frame: 0 and 8-weeks
  description: Timed Arm Curl: Number of repetitions an arm curl individuals can complete in 30 seconds)
  measure: Bellarmine Norton Assessment Tool (30 second Chair Stand)
  time frame: 0 and 8-weeks
  description: Chair Stand: Number of times participants can stand from a sitting position and return to sitting in 30 seconds
  measure: Fatigue
  time frame: 0 and 8-weeks
  description: The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: The FACIT-Fatigue scale is a 13-item scale that will be used to assess cancer-related fatigue. The FACIT-Fatigue scale is scored on a 0-4 response scale from 0 = "not at all" to 4 "very much", regarding items related to fatigue and energy in the past 7 days. Lower score indicates greater fatigue
  arm group label: Exercise
  arm group type: Experimental
  description: 2 days/week of resistance and cardiovascular exercise for 8-weeks
  intervention type: Behavioral
  intervention name: Exercise
  description: A combination of resistance exercise and cardiovascular exercise (performed 2 days per week for 8-weeks) is tailored to each individual in accordance with their medical/cancer-related history, baseline assessments of physical function, and overall goals.
  Resistance exercise includes 6-8 exercises targeting major muscle groups. The first week of the program is used to familiarize participants to the exercises of the program, provide coaching on safe and appropriate technique, and identifying initial load for 2 sets of 12 repetitions (equivalent to ~65% 1 repetition maximum), with a goal of working towards 4 sets of 8 reps. Additionally, participants are asked to perform 20-30 minutes of moderate-to-vigorous aerobic activity (approximately 60-85% age-predicted heart rate maximum) via walking, jogging, or cycling each session.
  arm group label: Exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of South Carolina
  investigator full name: Ciaran Fairman
  investigator title: Assistant Professor
  sharing ipd: No