<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/NCT03808363</url>
  </required_header>
  <id_info>
    <org_study_id>18-022-DITOR</org_study_id>
    <nct_id>NCT03808363</nct_id>
  </id_info>
  <brief_title>Effectiveness of High Intensity Interval Training (HIIT) on Improving Cardiometabolic Health After SCI</brief_title>
  <official_title>High-intensity Interval Training Versus Moderate Intensity Continuous Training as a Means to Improve Cardiometabolic Health After Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brock University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brock University</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>
      Testing the efficacy of high intensity interval training (HIIT), as compared to current&#xD;
      research supporting moderate intensity continuous training (MICT), as a means to improve&#xD;
      cardiometabolic health after spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to challenge the effectiveness of the current aerobic exercise&#xD;
      recommendations for individuals with spinal cord injuries (SCI). Currently, moderate&#xD;
      intensity continuous training (MICT) is suggested however this study intends to explore the&#xD;
      effectiveness of high intensity interval training (HIIT). To do so, approximately 8&#xD;
      individuals with SCI will be undergo a 6 week HIIT intervention consisting of 3 sessions per&#xD;
      week. With a focus on cardiometabolic health markers (listed in outcome measure section), we&#xD;
      aim to provide support for HIIT as a viable method of mitigating cardiovascular risk in a SCI&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">December 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2019</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>
    <intervention_model_description>6 week exercise intervention testing the efficacy of high intensity interval training as compared to current research supporting moderate intensity continuous exercise as a means to mitigate cardiometabolic decline following spinal cord injury</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Waist circumference (inches)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Central adiposity will be measured by tape measure to monitor possible weight loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>6 weeks</time_frame>
    <description>Total and HDL cholesterol will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>6 weeks</time_frame>
    <description>Triglycerides will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glycated Hemoglobin (HbA1c)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tumor necrosis factor (TNF-a)</measure>
    <time_frame>6 weeks</time_frame>
    <description>TNF-a will be used as an inflammatory representative and will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interleukin - 10 (IL-10)</measure>
    <time_frame>6 weeks</time_frame>
    <description>IL-10 will will be used as an anti-inflammatory representative and will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse Wave Velocity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Arterial stiffness, a common measure for cardiac risk will be measured</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measured through a digital cuff, the focus will be on both systolic and diastolic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peak Oxygen Consumption (VO2 peak)</measure>
    <time_frame>6 weeks</time_frame>
    <description>VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C Reactive Protein (CRP)</measure>
    <time_frame>6 weeks</time_frame>
    <description>CRP will will be used as an inflammatory representative and will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leptin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Leptin will will be used as a body fat representative and will be measured in serum</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adiponectin</measure>
    <time_frame>6 weeks</time_frame>
    <description>Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Activity Enjoyment Scale (PACES)</measure>
    <time_frame>6 weeks</time_frame>
    <description>All participants will complete the physical activity enjoyment scale (PACES) to indicate enjoyment of HIIT. With a total of 18 questions, options 1 through 7 going from a positive to a negative overall experience with the HIIT protocol will be documented.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Metabolic Syndrome</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>High Intensity Interval Training Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Intensity Interval Training</intervention_name>
    <description>Participants assigned to this group will perform a very mild 5-minute warm-up (0 resistance, and 60 rpm), followed by 5 one-minute bouts of high intensity exercise, with 90 seconds between each bout. These bouts will be followed by a 3-minute cool down (0 resistance, and 60 rpm). The high-intensity exercise will be performed at an intensity of 17 on the Borg rating of perceived exertion (RPE) scale (very hard), and the 90 second active rest intervals will be performed at an intensity of 7-9 (very, very light - very light). The exercise will be performed on the NuStep machine 3 times a week for 6 weeks.</description>
    <arm_group_label>High Intensity Interval Training Group</arm_group_label>
    <other_name>HIIT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with a spinal cord injury (paraplegia or tetraplegia, complete or&#xD;
             incomplete) who are at least one-year post injury.&#xD;
&#xD;
          -  Declared medically stable, and able to communicate clearly in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mitchel Gibson, BKin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masters Student</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aaron Donst, BKin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masters Student</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brock University</name>
      <address>
        <city>St. Catherines</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brock University</investigator_affiliation>
    <investigator_full_name>David Ditor</investigator_full_name>
    <investigator_title>David Ditor, PhD - Professor, Kinesiology</investigator_title>
  </responsible_party>
  <keyword>Metabolic Syndrome</keyword>
  <keyword>Spinal Cord Injury</keyword>
  <keyword>Cardiovascular Disease</keyword>
  <keyword>High Intensity Interval Training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03808363
org study id: 18-022-DITOR
nct id: NCT03808363
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Testing the efficacy of high intensity interval training (HIIT), as compared to current
      research supporting moderate intensity continuous training (MICT), as a means to improve
      cardiometabolic health after spinal cord injury.
This study aims to challenge the effectiveness of the current aerobic exercise
      recommendations for individuals with spinal cord injuries (SCI). Currently, moderate
      intensity continuous training (MICT) is suggested however this study intends to explore the
      effectiveness of high intensity interval training (HIIT). To do so, approximately 8
      individuals with SCI will be undergo a 6 week HIIT intervention consisting of 3 sessions per
      week. With a focus on cardiometabolic health markers (listed in outcome measure section), we
      aim to provide support for HIIT as a viable method of mitigating cardiovascular risk in a SCI
      population.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 6 week exercise intervention testing the efficacy of high intensity interval training as compared to current research supporting moderate intensity continuous exercise as a means to mitigate cardiometabolic decline following spinal cord injury
primary purpose: Prevention
masking: None (Open Label)
measure: Waist circumference (inches)
time frame: 6 weeks
description: Central adiposity will be measured by tape measure to monitor possible weight loss
measure: Cholesterol
time frame: 6 weeks
description: Total and HDL cholesterol will be measured in serum
measure: Triglycerides
time frame: 6 weeks
description: Triglycerides will be measured in serum
measure: Glycated Hemoglobin (HbA1c)
time frame: 6 weeks
description: Glycated hemoglobin will be measured in whole blood as an indicator of diabetic risk
measure: Tumor necrosis factor (TNF-a)
time frame: 6 weeks
description: TNF-a will be used as an inflammatory representative and will be measured in serum
measure: Interleukin - 10 (IL-10)
time frame: 6 weeks
description: IL-10 will will be used as an anti-inflammatory representative and will be measured in serum
measure: Pulse Wave Velocity
time frame: 6 weeks
description: Arterial stiffness, a common measure for cardiac risk will be measured
measure: Blood pressure
time frame: 6 weeks
description: Measured through a digital cuff, the focus will be on both systolic and diastolic
measure: Peak Oxygen Consumption (VO2 peak)
time frame: 6 weeks
description: VO2 peak will be measured by a Moxus metabolic cart to determine changes in fitness
measure: C Reactive Protein (CRP)
time frame: 6 weeks
description: CRP will will be used as an inflammatory representative and will be measured in serum
measure: Leptin
time frame: 6 weeks
description: Leptin will will be used as a body fat representative and will be measured in serum
measure: Adiponectin
time frame: 6 weeks
description: Adiponectin will will be used as a surrogate for insulin resistance and will be measured in serum
measure: Physical Activity Enjoyment Scale (PACES)
time frame: 6 weeks
description: All participants will complete the physical activity enjoyment scale (PACES) to indicate enjoyment of HIIT. With a total of 18 questions, options 1 through 7 going from a positive to a negative overall experience with the HIIT protocol will be documented.
arm group label: High Intensity Interval Training Group
arm group type: Experimental
description: Approximately eight individuals with spinal cord injuries will participate in high intensity interval training for 6 weeks
intervention type: Other
intervention name: High Intensity Interval Training
description: Participants assigned to this group will perform a very mild 5-minute warm-up (0 resistance, and 60 rpm), followed by 5 one-minute bouts of high intensity exercise, with 90 seconds between each bout. These bouts will be followed by a 3-minute cool down (0 resistance, and 60 rpm). The high-intensity exercise will be performed at an intensity of 17 on the Borg rating of perceived exertion (RPE) scale (very hard), and the 90 second active rest intervals will be performed at an intensity of 7-9 (very, very light - very light). The exercise will be performed on the NuStep machine 3 times a week for 6 weeks.
arm group label: High Intensity Interval Training Group
other name: HIIT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mitchel Gibson, BKin
role: Principal Investigator
affiliation: Masters Student
last name: Aaron Donst, BKin
role: Principal Investigator
affiliation: Masters Student
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Brock University
investigator full name: David Ditor
investigator title: David Ditor, PhD - Professor, Kinesiology
mesh term: Cardiovascular Diseases
mesh term: Metabolic Syndrome
sharing ipd: No