<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/NCT03253900</url>
  </required_header>
  <id_info>
    <org_study_id>UP-FVZ-RowingBiomechanics</org_study_id>
    <nct_id>NCT03253900</nct_id>
  </id_info>
  <brief_title>Rowing Biomechanics - Effects of (In)Stability and Fatigue</brief_title>
  <acronym>RowBio</acronym>
  <official_title>Changes of Biomechanical Parameters During Race Simulation Rowing - The Effect of (In)Stability of the Simulator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Primorska</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Primorska</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>
      Rowing simulators are frequently used by rowers, when on-water training is impossible or&#xD;
      limited. While such devices are highly valuable to maintain rowers' fitness, a concern was&#xD;
      raised about extensive simulator usage. It was postulated that it could lead to technique&#xD;
      alterations due to different biomechanical properties compared to on-water rowing.&#xD;
      Slide-based rowing simulators were designed to better simulate on-water conditions.&#xD;
&#xD;
      The main aim of the study was to compare the differences in various kinematic and kinetic&#xD;
      parameters during a short (20 s) all-out rowing bout and during a 2000-m simulated race, to&#xD;
      get a better insight into how different rowing simulator designs affect biomechanics of&#xD;
      rowing.&#xD;
&#xD;
      Three different rowing simulators were used in this study: (1) a standard stable/fixed rowing&#xD;
      simulator, (2) a slides based rowing simulator, i.e. horizontal plane unstable, and (3) a&#xD;
      tilt board based rowing simulator; i.e. frontal plane unstable.&#xD;
&#xD;
      The investigators hypothesised that rowing on different simulators will elicit different&#xD;
      biomechanics, including forces, power output, arm and seat movement velocity and amplitude.&#xD;
&#xD;
      Each of the participants completed the tests in all three interventions on separate sessions;&#xD;
      random order of interventions. The three sessions took place 7-10 days apart. During each&#xD;
      session, the participants completed the all-out 20-s trial first, then the simulated 2000-m&#xD;
      race. The aforementioned biomechanical parameters were tracked throughout the trials to be&#xD;
      compared between interventions later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The measurements will take place at University of Primorska (Koper, Slovenia) and the&#xD;
      subjects will be recruited in close collaboration with Rowing Club Piran. Crossover study&#xD;
      design will be used. Each participant will be asked to come for three visits that will be&#xD;
      scheduled 7-10 days apart. Prior to measurements onset, the whole protocol will be explained&#xD;
      to the participant.&#xD;
&#xD;
      Measurement procedure:&#xD;
&#xD;
        -  15-min warm-up&#xD;
&#xD;
        -  20-s maximal (all-out) rowing&#xD;
&#xD;
        -  5-minute break&#xD;
&#xD;
        -  2000-m simulated race&#xD;
&#xD;
      After both trials, blood lactate will be measured. Blood sample will be taken at the the&#xD;
      earlobe by a qualified medical personnel.&#xD;
&#xD;
      Maximal performance test: The participant will perform a 20-s interval with maximal effort.&#xD;
      The main aim of the measurement is to record the maximal exerted force and power. The custom&#xD;
      adapted device (Concept 2 Rowing Simulator) records the positions (seat and handle) and force&#xD;
      (legs push and handle pull), which enables for further calculations of segmental and common&#xD;
      kinematics and dynamics parameters.&#xD;
&#xD;
      Race simulation: the participant will complete the 2000-m simulated race and will be&#xD;
      instructed to aim for the best results. The same measurements as in the maximal performance&#xD;
      test will be performed. Wireless heart rate monitor will be used to record the heart&#xD;
      frequency throughout the trial.&#xD;
&#xD;
      Equipment:&#xD;
&#xD;
      The custom adapted rowing simulator (Concept 2) allows for the measurements of stoke forces&#xD;
      and consequently power outputs, seat and handle velocity, and seat and handle amplitudes.&#xD;
      Signals will be transferred to central unit, amplified and converted, and stored on a&#xD;
      personal computer.&#xD;
&#xD;
      The interventions (i.e. the studied rowing conditions) will be as follows:&#xD;
&#xD;
        -  a standard stable/fixed rowing simulator,&#xD;
&#xD;
        -  a slides based rowing simulator, i.e. horizontal plane unstable, and&#xD;
&#xD;
        -  a tilt board based rowing simulator; i.e. frontal plane unstable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">July 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 1, 2016</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>All participants in the study will complete the measurements for all the three rowing interventions; in a random order.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The investigator who processed the acquired data was blinded for rowing interventions and subject information.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rowing performance</measure>
    <time_frame>Three sessions, with randomized order of ergometers (7-10 days apart)</time_frame>
    <description>Rowing biomechanics on different rowing simulators.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arm velocity</measure>
    <time_frame>At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.</time_frame>
    <description>Change of the average velocity of arm movement through the rowing stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seat velocity</measure>
    <time_frame>At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.</time_frame>
    <description>Change of the average velocity of the seat movement through the rowing stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm force</measure>
    <time_frame>At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.</time_frame>
    <description>Change of the average arm force through the rowing stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Handle amplitude</measure>
    <time_frame>At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.</time_frame>
    <description>Change of the average handle through the rowing stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leg force</measure>
    <time_frame>At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.</time_frame>
    <description>Change of the average leg force through the rowing stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seat amplitude</measure>
    <time_frame>At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.</time_frame>
    <description>Change of the average amplitude of the seat movement through the rowing stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate</measure>
    <time_frame>Before and immediately after the test, ref. POM: sessions 7-10 days apart. .</time_frame>
    <description>Change in blood lactate concentration</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A group of rowers to be administered to intervention on a Stable rowing simulator, a Slides based rowing simulator or a Tilt board based rowing simulator.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stable rowing simulator</intervention_name>
    <description>a standard stable/fixed rowing simulator</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Slides based rowing simulator</intervention_name>
    <description>a slides based rowing simulator, i.e. horizontal plane unstable</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tilt board based rowing simulator</intervention_name>
    <description>a tilt board based rowing simulator; i.e. frontal plane unstable</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Competitive rowers with at least 4 years of experience&#xD;
&#xD;
          -  Completed the physical examination at sports physician&#xD;
&#xD;
          -  Parental consent for underage participants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Injury in last 12 months&#xD;
&#xD;
          -  Any health issues that may be exacerbated by interventions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Primorska</investigator_affiliation>
    <investigator_full_name>Nejc Sarabon</investigator_full_name>
    <investigator_title>Assoc. Prof. Dr. Sc.</investigator_title>
  </responsible_party>
  <keyword>wobble board</keyword>
  <keyword>slides</keyword>
  <keyword>rowing stroke</keyword>
  <keyword>rowing biomechanics</keyword>
  <keyword>power output</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03253900
org study id: UP-FVZ-RowingBiomechanics
nct id: NCT03253900
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rowing simulators are frequently used by rowers, when on-water training is impossible or
      limited. While such devices are highly valuable to maintain rowers' fitness, a concern was
      raised about extensive simulator usage. It was postulated that it could lead to technique
      alterations due to different biomechanical properties compared to on-water rowing.
      Slide-based rowing simulators were designed to better simulate on-water conditions.

      The main aim of the study was to compare the differences in various kinematic and kinetic
      parameters during a short (20 s) all-out rowing bout and during a 2000-m simulated race, to
      get a better insight into how different rowing simulator designs affect biomechanics of
      rowing.

      Three different rowing simulators were used in this study: (1) a standard stable/fixed rowing
      simulator, (2) a slides based rowing simulator, i.e. horizontal plane unstable, and (3) a
      tilt board based rowing simulator; i.e. frontal plane unstable.

      The investigators hypothesised that rowing on different simulators will elicit different
      biomechanics, including forces, power output, arm and seat movement velocity and amplitude.

      Each of the participants completed the tests in all three interventions on separate sessions;
      random order of interventions. The three sessions took place 7-10 days apart. During each
      session, the participants completed the all-out 20-s trial first, then the simulated 2000-m
      race. The aforementioned biomechanical parameters were tracked throughout the trials to be
      compared between interventions later.
The measurements will take place at University of Primorska (Koper, Slovenia) and the
      subjects will be recruited in close collaboration with Rowing Club Piran. Crossover study
      design will be used. Each participant will be asked to come for three visits that will be
      scheduled 7-10 days apart. Prior to measurements onset, the whole protocol will be explained
      to the participant.

      Measurement procedure:

        -  15-min warm-up

        -  20-s maximal (all-out) rowing

        -  5-minute break

        -  2000-m simulated race

      After both trials, blood lactate will be measured. Blood sample will be taken at the the
      earlobe by a qualified medical personnel.

      Maximal performance test: The participant will perform a 20-s interval with maximal effort.
      The main aim of the measurement is to record the maximal exerted force and power. The custom
      adapted device (Concept 2 Rowing Simulator) records the positions (seat and handle) and force
      (legs push and handle pull), which enables for further calculations of segmental and common
      kinematics and dynamics parameters.

      Race simulation: the participant will complete the 2000-m simulated race and will be
      instructed to aim for the best results. The same measurements as in the maximal performance
      test will be performed. Wireless heart rate monitor will be used to record the heart
      frequency throughout the trial.

      Equipment:

      The custom adapted rowing simulator (Concept 2) allows for the measurements of stoke forces
      and consequently power outputs, seat and handle velocity, and seat and handle amplitudes.
      Signals will be transferred to central unit, amplified and converted, and stored on a
      personal computer.

      The interventions (i.e. the studied rowing conditions) will be as follows:

        -  a standard stable/fixed rowing simulator,

        -  a slides based rowing simulator, i.e. horizontal plane unstable, and

        -  a tilt board based rowing simulator; i.e. frontal plane unstable.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants in the study will complete the measurements for all the three rowing interventions; in a random order.
primary purpose: Basic Science
masking: None (Open Label)
masking description: The investigator who processed the acquired data was blinded for rowing interventions and subject information.
measure: Rowing performance
time frame: Three sessions, with randomized order of ergometers (7-10 days apart)
description: Rowing biomechanics on different rowing simulators.
measure: Arm velocity
time frame: At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.
description: Change of the average velocity of arm movement through the rowing stroke.
measure: Seat velocity
time frame: At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.
description: Change of the average velocity of the seat movement through the rowing stroke.
measure: Arm force
time frame: At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.
description: Change of the average arm force through the rowing stroke.
measure: Handle amplitude
time frame: At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.
description: Change of the average handle through the rowing stroke.
measure: Leg force
time frame: At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.
description: Change of the average leg force through the rowing stroke.
measure: Seat amplitude
time frame: At the onset of test, at the finish and at the three points in between (at 500, 1000 and 1500 meters of the simulated race) - ref. POM: sessions 7-10 days apart.
description: Change of the average amplitude of the seat movement through the rowing stroke.
measure: Lactate
time frame: Before and immediately after the test, ref. POM: sessions 7-10 days apart. .
description: Change in blood lactate concentration
arm group label: Experimental group
arm group type: Experimental
description: A group of rowers to be administered to intervention on a Stable rowing simulator, a Slides based rowing simulator or a Tilt board based rowing simulator.
intervention type: Device
intervention name: Stable rowing simulator
description: a standard stable/fixed rowing simulator
arm group label: Experimental group
intervention type: Device
intervention name: Slides based rowing simulator
description: a slides based rowing simulator, i.e. horizontal plane unstable
arm group label: Experimental group
intervention type: Device
intervention name: Tilt board based rowing simulator
description: a tilt board based rowing simulator; i.e. frontal plane unstable
arm group label: Experimental group
criteria: 
gender: Male
minimum age: 15 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Primorska
investigator full name: Nejc Sarabon
investigator title: Assoc. Prof. Dr. Sc.
sharing ipd: Undecided