<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/NCT04465825</url>
  </required_header>
  <id_info>
    <org_study_id>HS22987</org_study_id>
    <nct_id>NCT04465825</nct_id>
  </id_info>
  <brief_title>Developing Strategies to Optimize the Exercise Response After Tetraplegia.</brief_title>
  <official_title>Developing Strategies to Optimize the Exercise Response in Persons Living With Tetraplegia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</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>
      To identify means to improve exercise performance in participants with tetraplegia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part I. This study will examine the relationship between steady-state and peak exercise&#xD;
      performance in participants with tetraplegia or paraplegia.&#xD;
&#xD;
      Participants will have their peak energy expenditure measured using a discontinuous step&#xD;
      test. Participants will then perform three different trials of exercise at a steady state at&#xD;
      a target intensity that corresponds with 90%, 70%, and 60% of their own measured peak energy&#xD;
      expense. Participants will exercise at the prescribed power output until fatigue.&#xD;
      Participants may choose which exercise mode they use (with all steady-state trials being in&#xD;
      the same mode as the peak test), and may choose to perform the study twice in the different&#xD;
      exercise modes. Exercise trials will be performed over a number of different sessions in a&#xD;
      randomized order, allowing for adequate rest and recovery between trials, and depending on&#xD;
      each participant's capabilities and preferences.&#xD;
&#xD;
      Part II. This study will determine if high intensity interval training (HIIT) results in&#xD;
      greater energy expense than constant rate aerobic exercise, and will test if exercising with&#xD;
      HITT effects time to fatigue.&#xD;
&#xD;
      Participants will exercise using a high intensity interval training (HIIT) protocol, which&#xD;
      involves alternating high intensity bouts of short duration with low intensity bouts of&#xD;
      longer duration. Participants will have their peak energy expenditure measured using a&#xD;
      discontinuous step test. Participants will then perform one trial of steady-state exercise at&#xD;
      a target intensity that corresponds with 50% of their peak energy expense, for a target of&#xD;
      20-45 minutes. Participants will perform a separate trial using a HIIT protocol of exercise&#xD;
      at a target intensity that corresponds with 50% of their peak energy expense interspersed&#xD;
      with bouts of high intensity (target intensity that corresponds with 90% of peak energy&#xD;
      expense) for 30-60 seconds, for a total duration target of 20-45 minutes.&#xD;
&#xD;
      Participants may choose which exercise mode they use (with all trials being in the same mode&#xD;
      as the peak test), and may choose to perform the study twice in the different exercise modes.&#xD;
      Exercise trials will be performed over a number of different sessions in a randomized order,&#xD;
      allowing for adequate rest and recovery between trials, and depending on each participant's&#xD;
      capabilities and preferences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>
    <intervention_model_description>Part 2 is a randomized crossover design.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy expenditure in ml of oxygen consumed per minute per kg of body weight</measure>
    <time_frame>Measured during 20-40 minutes of exercise</time_frame>
    <description>Estimation of energy expenditure for bout of exercise</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to fatigue</measure>
    <time_frame>Measured during 20-40 minutes of exercise</time_frame>
    <description>Total duration of exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratings of perceived exertion</measure>
    <time_frame>Measured during 20-40 minutes of exercise</time_frame>
    <description>Ratings of perceived exertion during exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Measured during 20-40 minutes of exercise</time_frame>
    <description>We will examine differences in average, peak HR and HR variability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <condition>Spinal Cord Injury Cervical</condition>
  <condition>Paraplegia, Spinal</condition>
  <arm_group>
    <arm_group_label>Interspersing HITT in exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will test whether introducing HITT into an acute exercise bout will increase overall energy expenditure or time to fatigue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acute exercise bout with no HITT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Exercise will occur at 50% peak without introducing HITT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HITT: intermittent high intensity exercise</intervention_name>
    <description>Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).</description>
    <arm_group_label>Interspersing HITT in exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Spinal cord injury of at least one year duration, C5-T12, ASIA impairment scale (AIS)&#xD;
             A-D&#xD;
&#xD;
          -  Aged 18-75 years for the duration of the study participation&#xD;
&#xD;
          -  Medically stable and healthy enough to engage in and complete exercise requirements&#xD;
&#xD;
          -  Willing and able to complete the exercise protocols and testing requirements&#xD;
&#xD;
          -  Able to understand and follow written and verbal instructions from study staff&#xD;
&#xD;
          -  Able to communicate with study staff about their exercise capabilities and preferences&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current serious injury(ies) of the upper extremities&#xD;
&#xD;
          -  Known cardiovascular disease&#xD;
&#xD;
          -  Unsatisfactory results of EKG screening&#xD;
&#xD;
          -  Implanted electronic cardiac device (e.g. pace maker, defibrillator, etc.)&#xD;
&#xD;
          -  Current pressure ulcer(s)&#xD;
&#xD;
          -  Morbid obesity&#xD;
&#xD;
          -  Known thyroid dysfunction&#xD;
&#xD;
          -  Current cancer&#xD;
&#xD;
          -  Current uncontrolled high blood pressure ( &gt; 140/90 mmHg)&#xD;
&#xD;
          -  Uncontrolled epilepsy&#xD;
&#xD;
          -  Current deep vein thrombosis&#xD;
&#xD;
          -  Ventilator-dependent&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kristine C Cowley, Ph.D.</last_name>
    <phone>2047893305</phone>
    <email>kristine.cowley@umanitoba.ca</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>May 11, 2021</last_update_submitted>
  <last_update_submitted_qc>May 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Paraplegia</mesh_term>
    <mesh_term>Quadriplegia</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Once published we will strive to make anonymized study data available.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The data will be available once published for one year.</ipd_time_frame>
  </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/NCT04465825
org study id: HS22987
nct id: NCT04465825
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To identify means to improve exercise performance in participants with tetraplegia.
Part I. This study will examine the relationship between steady-state and peak exercise
      performance in participants with tetraplegia or paraplegia.

      Participants will have their peak energy expenditure measured using a discontinuous step
      test. Participants will then perform three different trials of exercise at a steady state at
      a target intensity that corresponds with 90%, 70%, and 60% of their own measured peak energy
      expense. Participants will exercise at the prescribed power output until fatigue.
      Participants may choose which exercise mode they use (with all steady-state trials being in
      the same mode as the peak test), and may choose to perform the study twice in the different
      exercise modes. Exercise trials will be performed over a number of different sessions in a
      randomized order, allowing for adequate rest and recovery between trials, and depending on
      each participant's capabilities and preferences.

      Part II. This study will determine if high intensity interval training (HIIT) results in
      greater energy expense than constant rate aerobic exercise, and will test if exercising with
      HITT effects time to fatigue.

      Participants will exercise using a high intensity interval training (HIIT) protocol, which
      involves alternating high intensity bouts of short duration with low intensity bouts of
      longer duration. Participants will have their peak energy expenditure measured using a
      discontinuous step test. Participants will then perform one trial of steady-state exercise at
      a target intensity that corresponds with 50% of their peak energy expense, for a target of
      20-45 minutes. Participants will perform a separate trial using a HIIT protocol of exercise
      at a target intensity that corresponds with 50% of their peak energy expense interspersed
      with bouts of high intensity (target intensity that corresponds with 90% of peak energy
      expense) for 30-60 seconds, for a total duration target of 20-45 minutes.

      Participants may choose which exercise mode they use (with all trials being in the same mode
      as the peak test), and may choose to perform the study twice in the different exercise modes.
      Exercise trials will be performed over a number of different sessions in a randomized order,
      allowing for adequate rest and recovery between trials, and depending on each participant's
      capabilities and preferences.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Part 2 is a randomized crossover design.
primary purpose: Basic Science
masking: None (Open Label)
measure: Energy expenditure in ml of oxygen consumed per minute per kg of body weight
time frame: Measured during 20-40 minutes of exercise
description: Estimation of energy expenditure for bout of exercise
measure: Time to fatigue
time frame: Measured during 20-40 minutes of exercise
description: Total duration of exercise
measure: Ratings of perceived exertion
time frame: Measured during 20-40 minutes of exercise
description: Ratings of perceived exertion during exercise
measure: Heart rate
time frame: Measured during 20-40 minutes of exercise
description: We will examine differences in average, peak HR and HR variability
arm group label: Interspersing HITT in exercise
arm group type: Active Comparator
description: We will test whether introducing HITT into an acute exercise bout will increase overall energy expenditure or time to fatigue.
arm group label: Acute exercise bout with no HITT
arm group type: No Intervention
description: Exercise will occur at 50% peak without introducing HITT.
intervention type: Behavioral
intervention name: HITT: intermittent high intensity exercise
description: Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).
arm group label: Interspersing HITT in exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Kristine C Cowley, Ph.D.
phone: 2047893305
email: kristine.cowley@umanitoba.ca
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Paraplegia
mesh term: Quadriplegia
mesh term: Wounds and Injuries
sharing ipd: Yes
ipd description: Once published we will strive to make anonymized study data available.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: The data will be available once published for one year.