<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/NCT03284086</url>
  </required_header>
  <id_info>
    <org_study_id>2015/2008</org_study_id>
    <nct_id>NCT03284086</nct_id>
  </id_info>
  <brief_title>VO2peak and Exercise Efficiency in Upper-body Poling</brief_title>
  <official_title>Comparison of Peak Oxygen Uptake and Exercise Efficiency Between Upper-body Poling and Arm Crank Ergometry in Trained Paraplegic and Able-bodied Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Norwegian University of Science and Technology</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>
      This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling&#xD;
      versus arm crank ergometry in trained able-bodied and paraplegic participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance&#xD;
      performance. In persons who are primarily able to use their upper-body during exercise, such&#xD;
      as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency&#xD;
      is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested&#xD;
      to be of importance for achieving VO2peak and exercise efficiency that are reflective of the&#xD;
      aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit&#xD;
      skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode.&#xD;
      However, it has not yet been investigated whether VO2peak and efficiency differ between ACE&#xD;
      and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in&#xD;
      upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic&#xD;
      participants. Participants performed four 5-min submaximal stages at increasing effort and an&#xD;
      incremental peak test to exhaustion in both ACE and UP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak oxygen uptake</measure>
    <time_frame>3 weeks</time_frame>
    <description>Peak oxygen uptake was measured during an incremental test to exhaustion.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>paraplegic</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Well-trained participants with a spinal cord injury (&lt;Th1) were included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>able bodied</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Upper-body trained, able-bodied participants were included in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>upper-body double-poling</intervention_name>
    <description>An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode.</description>
    <arm_group_label>able bodied</arm_group_label>
    <arm_group_label>paraplegic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>arm crank ergometry</intervention_name>
    <description>An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode.</description>
    <arm_group_label>able bodied</arm_group_label>
    <arm_group_label>paraplegic</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants between the age of 18 and 50&#xD;
&#xD;
          -  well upper-body-trained participants with or without paraplegia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people with injuries or sicknesses that might have impacted the testing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorunn Helbostad, phd prof</last_name>
    <role>Study Director</role>
    <affiliation>Dept of Neuromedicine and Movement Science, Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Elite Sports Research</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oxygen consumption</keyword>
  <keyword>Physical endurance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All data will be de-identified by the project coordinator. The de-identified data will be stored on the NTNU server in a folder that only the JKB and ØS have access to. For analysing the data, parts of the de-identified data might be distributed amongst the four researchers and two master students linked to this study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>September 2016-May 2017</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/NCT03284086
org study id: 2015/2008
nct id: NCT03284086
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling
      versus arm crank ergometry in trained able-bodied and paraplegic participants.
Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance
      performance. In persons who are primarily able to use their upper-body during exercise, such
      as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency
      is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested
      to be of importance for achieving VO2peak and exercise efficiency that are reflective of the
      aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit
      skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode.
      However, it has not yet been investigated whether VO2peak and efficiency differ between ACE
      and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in
      upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic
      participants. Participants performed four 5-min submaximal stages at increasing effort and an
      incremental peak test to exhaustion in both ACE and UP.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Peak oxygen uptake
time frame: 3 weeks
description: Peak oxygen uptake was measured during an incremental test to exhaustion.
arm group label: paraplegic
arm group type: Other
description: Well-trained participants with a spinal cord injury (<Th1) were included in this group.
arm group label: able bodied
arm group type: Other
description: Upper-body trained, able-bodied participants were included in this group.
intervention type: Diagnostic Test
intervention name: upper-body double-poling
description: An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode.
arm group label: able bodied
arm group label: paraplegic
intervention type: Diagnostic Test
intervention name: arm crank ergometry
description: An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode.
arm group label: able bodied
arm group label: paraplegic
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jorunn Helbostad, phd prof
role: Study Director
affiliation: Dept of Neuromedicine and Movement Science, Norwegian University of Science and Technology
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
sharing ipd: Yes
ipd description: All data will be de-identified by the project coordinator. The de-identified data will be stored on the NTNU server in a folder that only the JKB and ØS have access to. For analysing the data, parts of the de-identified data might be distributed amongst the four researchers and two master students linked to this study.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: September 2016-May 2017