<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/NCT02188342</url>
  </required_header>
  <id_info>
    <org_study_id>HITCa</org_study_id>
    <nct_id>NCT02188342</nct_id>
  </id_info>
  <brief_title>Assessing The Effectiveness of a Preoperative High Intensity Interval Training Programme In Older Colorectal Cancer Patients</brief_title>
  <acronym>HITCa</acronym>
  <official_title>Effectiveness of Short Term, High Intensity, Interval Exercise Training in Older Colorectal Cancer Patients in Improving Preoperative Fitness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals of Derby and Burton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to determine whether an improvement in aerobic fitness, as&#xD;
      judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group&#xD;
      of older, colorectal cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      12 high intensity interval training exercise sessions on a static cycle ergometer, over a&#xD;
      period of 31 days. Each session lasts 18 minutes.&#xD;
&#xD;
      At the beginning and end of the study the following measures will be used to assess change in&#xD;
      fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling&#xD;
      test, short performance battery tests, quality of life questionnaires and muscle biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VO2 peak</measure>
    <time_frame>After 31 days of HIT</time_frame>
    <description>Mean difference in VO2 peak following a HIT programme</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anaerobic threshold</measure>
    <time_frame>After 31 days of HIT</time_frame>
    <description>Mean difference in anaerobic threshold following a HIT programme</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle protein synthesis</measure>
    <time_frame>After 31 days of HIT</time_frame>
    <description>Assessment of D2O evaluated muscle protein synthesis following HIT programme</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>After 31 days of HIT</time_frame>
    <description>DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility</measure>
    <time_frame>After 31 days of HIT</time_frame>
    <description>Determination of patient compliance and adherence to HIT programme</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>After 31 days of HIT</time_frame>
    <description>Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Preoperative Care</condition>
  <condition>Colorectal Neoplasms</condition>
  <condition>Aged</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>HIT exercise training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HIT</intervention_name>
    <description>12 HIT exercise sessions in 31 days on a stationary cycle ergometer</description>
    <arm_group_label>HIT exercise training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed colorectal cancer&#xD;
&#xD;
          -  Offered curative treatment by the Royal Derby Hospital NHS Foundation Trust Colorectal&#xD;
             Cancer Multidisciplinary Team&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  18-88 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension (BP &gt; 160/100),&#xD;
&#xD;
          -  Angina,&#xD;
&#xD;
          -  Heart failure (class III/IV),&#xD;
&#xD;
          -  Cardiac arrthymias,&#xD;
&#xD;
          -  Right to left cardiac shunt,&#xD;
&#xD;
          -  Recent cardiac event,&#xD;
&#xD;
          -  Previous stroke/TIA,&#xD;
&#xD;
          -  Aneurysm (large vessel or intracranial),&#xD;
&#xD;
          -  Severe respiratory disease including pulmonary hypertension,&#xD;
&#xD;
          -  COPD/asthma with an FEV1 less than 1.5 l,&#xD;
&#xD;
          -  Coagulation disorders,&#xD;
&#xD;
          -  Scarring disorders.&#xD;
&#xD;
          -  Current neoadjuvant chemo/radiotherapy&#xD;
&#xD;
          -  Inability to complete the consent process Involvement in invasive research study in&#xD;
             previous 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>88 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Williams, BSc MBChB FRCA PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Nottingham</name>
      <address>
        <city>Derby</city>
        <state>Derbyshire</state>
        <zip>DE22 3DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02188342
org study id: HITCa
nct id: NCT02188342
lead sponsor: 
collaborator: 
has dmc: No
The primary aim of this study is to determine whether an improvement in aerobic fitness, as
      judged by an increase in VO2peak, can be achieved within 31 days via HIT programme in a group
      of older, colorectal cancer patients.
12 high intensity interval training exercise sessions on a static cycle ergometer, over a
      period of 31 days. Each session lasts 18 minutes.

      At the beginning and end of the study the following measures will be used to assess change in
      fitness, body composition and muscle metabolism. DXA scan, USS of thigh, VO2 peak cycling
      test, short performance battery tests, quality of life questionnaires and muscle biopsy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: VO2 peak
time frame: After 31 days of HIT
description: Mean difference in VO2 peak following a HIT programme
measure: Anaerobic threshold
time frame: After 31 days of HIT
description: Mean difference in anaerobic threshold following a HIT programme
measure: Muscle protein synthesis
time frame: After 31 days of HIT
description: Assessment of D2O evaluated muscle protein synthesis following HIT programme
measure: Body composition
time frame: After 31 days of HIT
description: DXA and USS assessed changes in lean muscle mass and architecture following a HIT programme
measure: Feasibility
time frame: After 31 days of HIT
description: Determination of patient compliance and adherence to HIT programme
measure: Quality of life
time frame: After 31 days of HIT
description: Quality of life and performance questionnaires to measure subjective outcomes (EQ-5D, IPAQ, DASI, WEMWBS)
arm group label: HIT exercise training
arm group type: Experimental
intervention type: Behavioral
intervention name: HIT
description: 12 HIT exercise sessions in 31 days on a stationary cycle ergometer
arm group label: HIT exercise training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 88 Years
healthy volunteers: No
last name: John Williams, BSc MBChB FRCA PhD
role: Principal Investigator
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Colorectal Neoplasms