<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/NCT04469361</url>
  </required_header>
  <id_info>
    <org_study_id>09.2017.129</org_study_id>
    <nct_id>NCT04469361</nct_id>
  </id_info>
  <brief_title>The Effect of Training on Hemodynamic Factors in Ballet Dancer</brief_title>
  <official_title>The Effect of Ballet Training on Plantar Venous Pump Activity in Ballerinas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Marmara 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>
      Classic ballet dance is a demonstration of complex motor skills to be revealed in aesthetic&#xD;
      combinations and repetitively, and it demands intensive use of the lower extremities within&#xD;
      extreme of range of motion (ROM). Because ballet practice depends on advanced technical&#xD;
      skills, it involves intensive physical training and causes an overload on the musculoskeletal&#xD;
      system and foot deformities such as pes planus.&#xD;
&#xD;
      Plantar venous pump (PVP) is a network of multiple venous vessels located between the muscles&#xD;
      of the foot arch. PVP is considered the first step of venous return and discharges into the&#xD;
      posterior tibial vein (PTV). PVP is reported to be active during gait while it is inactive in&#xD;
      resting position. There are different views on the mechanisms enabling its activation 1-3.&#xD;
      The general view is that during the stance phase of the gait, the flattening of the plantar&#xD;
      arch with weight transfer causes the veins in this region to narrow and creates a force that&#xD;
      pumps the blood up.&#xD;
&#xD;
      The aim of this study is the investigation what kind of hemodynamic changes ballet training&#xD;
      causes in the lower extremity&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">January 5, 2018</completion_date>
  <primary_completion_date type="Actual">November 3, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of navicular drop</measure>
    <time_frame>Cchange from baseline navicular height in pre-intervention and immediately after the intervention/</time_frame>
    <description>Navicular drop was measured in mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of diameter of tibialis posterior vein in supine</measure>
    <time_frame>Change from baseline diameter of tibialis posterior vein during intervention</time_frame>
    <description>Diameter of tibialis posterior vein was measured in mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of flow velocity of tibialis posterior vein in supine</measure>
    <time_frame>Change from baseline flow velocity of tibialis posterior vein during intervention</time_frame>
    <description>Flow velocity of tibialis posterior vein was measured in cm/s</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of volume flow of tibialis posterior vein in supine</measure>
    <time_frame>Change from baseline volume flow of tibialis posterior vein during intervention</time_frame>
    <description>Volume flow of tibialis posterior vein was measured in ml/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of diameter of tibialis posterior vein during weight bearing</measure>
    <time_frame>Change from baseline diameter of tibialis posterior during intervention</time_frame>
    <description>Diameter of tibialis posterior vein was measured in mm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of flow velocity of tibialis posterior vein during weight bearing</measure>
    <time_frame>Change from baseline flow velocity of tibialis posterior vein during intervention</time_frame>
    <description>Flow velocity of tibialis posterior vein was measured in cm/s</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of volume flow of tibialis posterior vein during weight bearing</measure>
    <time_frame>Change from baseline volume flow of tibialis posterior vein during intervention</time_frame>
    <description>Volume flow of tibialis posterior vein was measured in ml/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of midfoot plantar pressure during weight bearing</measure>
    <time_frame>Change from baseline midfoot pressure during intervention</time_frame>
    <description>Midfoot plantar pressure was measured in gr/cm2</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Venous Insufficiency</condition>
  <condition>Foot Drop (Acquired)</condition>
  <arm_group>
    <arm_group_label>Ballerinas</arm_group_label>
    <description>Balerina students who have trained at least for 4 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Female students</arm_group_label>
    <description>Female students with sedentary lifestyle</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Navicular drop measurement</intervention_name>
    <description>The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.</description>
    <arm_group_label>Ballerinas</arm_group_label>
    <arm_group_label>Female students</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of venous return parameters in supine</intervention_name>
    <description>Venous return parameters of posterior tibial vein was measured when participant applied force equivalent to their own body weight on plantar surface of their right leg in supine position</description>
    <arm_group_label>Ballerinas</arm_group_label>
    <arm_group_label>Female students</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of venous return parameters in standing</intervention_name>
    <description>In standing, venous return parameters was measured of posterior tibial vein when participants shift all of their weight to the right leg for 3 second with their leg muscles as relaxed as possible and their knee joint in full extension.</description>
    <arm_group_label>Ballerinas</arm_group_label>
    <arm_group_label>Female students</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>measurement of midfoot pressure distrubition</intervention_name>
    <description>In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg</description>
    <arm_group_label>Ballerinas</arm_group_label>
    <arm_group_label>Female students</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Ballerinas taking ballet training at least for 4 years and female sedentary students&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (for balerinas):&#xD;
&#xD;
          -  receiving ballet training at least 10 h per week for at least 4 years&#xD;
&#xD;
          -  receiving formal dancing training system&#xD;
&#xD;
        Inclusion Criteria (for non-dancer group)&#xD;
&#xD;
          -  never receiving formal dancing training&#xD;
&#xD;
          -  having sedentary lifestyle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with a history of foot or ankle surgery,&#xD;
&#xD;
          -  Participants with connective tissue disease,&#xD;
&#xD;
          -  Participants with rigid pes planus-cavus,&#xD;
&#xD;
          -  Participants with chronic venous insufficiency&#xD;
&#xD;
          -  Participants with acute ankle injury in recent 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>ballerinas and females students with sedentary life styles</gender_description>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nilüfer Kablan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marmara University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marmara University</name>
      <address>
        <city>Istanbul</city>
        <zip>34000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Guss-West C, Wulf G. Attentional Focus in Classical Ballet: A Survey Of Professional Dancers. J Dance Med Sci. 2016 Mar;20(1):23-9. doi: 10.12678/1089-313X.20.1.23.</citation>
    <PMID>27025449</PMID>
  </results_reference>
  <results_reference>
    <citation>Allen N, Nevill A, Brooks J, Koutedakis Y, Wyon M. Ballet injuries: injury incidence and severity over 1 year. J Orthop Sports Phys Ther. 2012 Sep;42(9):781-90. doi: 10.2519/jospt.2012.3893. Epub 2012 Jul 19.</citation>
    <PMID>22814244</PMID>
  </results_reference>
  <results_reference>
    <citation>Gardner AM, Fox RH. The venous pump of the human foot--preliminary report. Bristol Med Chir J. 1983 Jul;98(367):109-12. No abstract available.</citation>
    <PMID>6616290</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim TI, Forbang NI, Criqui MH, Allison MA. Association of foot and ankle characteristics with progression of venous disease. Vasc Med. 2015 Apr;20(2):105-11. doi: 10.1177/1358863X14568443.</citation>
    <PMID>25832598</PMID>
  </results_reference>
  <results_reference>
    <citation>Pearson SJ, Whitaker AF. Footwear in classical ballet: a study of pressure distribution and related foot injury in the adolescent dancer. J Dance Med Sci. 2012;16(2):51-6.</citation>
    <PMID>22687718</PMID>
  </results_reference>
  <results_reference>
    <citation>Khan K, Brown J, Way S, Vass N, Crichton K, Alexander R, Baxter A, Butler M, Wark J. Overuse injuries in classical ballet. Sports Med. 1995 May;19(5):341-57. doi: 10.2165/00007256-199519050-00004.</citation>
    <PMID>7618011</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</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>Peroneal Neuropathies</mesh_term>
    <mesh_term>Venous Insufficiency</mesh_term>
  </condition_browse>
  <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/NCT04469361
org study id: 09.2017.129
nct id: NCT04469361
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Classic ballet dance is a demonstration of complex motor skills to be revealed in aesthetic
      combinations and repetitively, and it demands intensive use of the lower extremities within
      extreme of range of motion (ROM). Because ballet practice depends on advanced technical
      skills, it involves intensive physical training and causes an overload on the musculoskeletal
      system and foot deformities such as pes planus.

      Plantar venous pump (PVP) is a network of multiple venous vessels located between the muscles
      of the foot arch. PVP is considered the first step of venous return and discharges into the
      posterior tibial vein (PTV). PVP is reported to be active during gait while it is inactive in
      resting position. There are different views on the mechanisms enabling its activation 1-3.
      The general view is that during the stance phase of the gait, the flattening of the plantar
      arch with weight transfer causes the veins in this region to narrow and creates a force that
      pumps the blood up.

      The aim of this study is the investigation what kind of hemodynamic changes ballet training
      causes in the lower extremity
observational model: Other
time perspective: Cross-Sectional
measure: Evaluation of navicular drop
time frame: Cchange from baseline navicular height in pre-intervention and immediately after the intervention/
description: Navicular drop was measured in mm
measure: Evaluation of diameter of tibialis posterior vein in supine
time frame: Change from baseline diameter of tibialis posterior vein during intervention
description: Diameter of tibialis posterior vein was measured in mm
measure: Evaluation of flow velocity of tibialis posterior vein in supine
time frame: Change from baseline flow velocity of tibialis posterior vein during intervention
description: Flow velocity of tibialis posterior vein was measured in cm/s
measure: Evaluation of volume flow of tibialis posterior vein in supine
time frame: Change from baseline volume flow of tibialis posterior vein during intervention
description: Volume flow of tibialis posterior vein was measured in ml/min
measure: Evaluation of diameter of tibialis posterior vein during weight bearing
time frame: Change from baseline diameter of tibialis posterior during intervention
description: Diameter of tibialis posterior vein was measured in mm
measure: Evaluation of flow velocity of tibialis posterior vein during weight bearing
time frame: Change from baseline flow velocity of tibialis posterior vein during intervention
description: Flow velocity of tibialis posterior vein was measured in cm/s
measure: Evaluation of volume flow of tibialis posterior vein during weight bearing
time frame: Change from baseline volume flow of tibialis posterior vein during intervention
description: Volume flow of tibialis posterior vein was measured in ml/min
measure: Evaluation of midfoot plantar pressure during weight bearing
time frame: Change from baseline midfoot pressure during intervention
description: Midfoot plantar pressure was measured in gr/cm2
arm group label: Ballerinas
description: Balerina students who have trained at least for 4 years
arm group label: Female students
description: Female students with sedentary lifestyle
intervention type: Other
intervention name: Navicular drop measurement
description: The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.
arm group label: Ballerinas
arm group label: Female students
intervention type: Other
intervention name: Measurement of venous return parameters in supine
description: Venous return parameters of posterior tibial vein was measured when participant applied force equivalent to their own body weight on plantar surface of their right leg in supine position
arm group label: Ballerinas
arm group label: Female students
intervention type: Other
intervention name: Measurement of venous return parameters in standing
description: In standing, venous return parameters was measured of posterior tibial vein when participants shift all of their weight to the right leg for 3 second with their leg muscles as relaxed as possible and their knee joint in full extension.
arm group label: Ballerinas
arm group label: Female students
intervention type: Other
intervention name: measurement of midfoot pressure distrubition
description: In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg
arm group label: Ballerinas
arm group label: Female students
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: ballerinas and females students with sedentary life styles
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nilüfer Kablan, PhD
role: Principal Investigator
affiliation: Marmara University
facility: 
country: Turkey
citation: Guss-West C, Wulf G. Attentional Focus in Classical Ballet: A Survey Of Professional Dancers. J Dance Med Sci. 2016 Mar;20(1):23-9. doi: 10.12678/1089-313X.20.1.23.
PMID: 27025449
citation: Allen N, Nevill A, Brooks J, Koutedakis Y, Wyon M. Ballet injuries: injury incidence and severity over 1 year. J Orthop Sports Phys Ther. 2012 Sep;42(9):781-90. doi: 10.2519/jospt.2012.3893. Epub 2012 Jul 19.
PMID: 22814244
citation: Gardner AM, Fox RH. The venous pump of the human foot--preliminary report. Bristol Med Chir J. 1983 Jul;98(367):109-12. No abstract available.
PMID: 6616290
citation: Kim TI, Forbang NI, Criqui MH, Allison MA. Association of foot and ankle characteristics with progression of venous disease. Vasc Med. 2015 Apr;20(2):105-11. doi: 10.1177/1358863X14568443.
PMID: 25832598
citation: Pearson SJ, Whitaker AF. Footwear in classical ballet: a study of pressure distribution and related foot injury in the adolescent dancer. J Dance Med Sci. 2012;16(2):51-6.
PMID: 22687718
citation: Khan K, Brown J, Way S, Vass N, Crichton K, Alexander R, Baxter A, Butler M, Wark J. Overuse injuries in classical ballet. Sports Med. 1995 May;19(5):341-57. doi: 10.2165/00007256-199519050-00004.
PMID: 7618011
responsible party type: Sponsor
mesh term: Peroneal Neuropathies
mesh term: Venous Insufficiency
sharing ipd: Undecided