xml: <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/NCT05998057</url>
    </required_header>
    <id_info>
      <org_study_id>Uskudar70</org_study_id>
      <nct_id>NCT05998057</nct_id>
    </id_info>
    <brief_title>The Effect of Neuromuscular Exercise Training on Balance, Jump and Trunk Endurance in Female Ice Hockey Players</brief_title>
    <official_title>The Effect of Neuromuscular Exercise Training on Balance, Jump and Trunk Endurance in Female Ice Hockey Players</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Uskudar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Uskudar 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>
        The aim of the study is to investigate the changes in dynamic balance, vertical jump and&#xD;
        trunk endurance parameters in athletes included in body weight neuromuscular program in&#xD;
        addition to regular training programs.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        As a randomization method, the participants will be divided into two groups as control and&#xD;
        experimental groups by using a computer-based program and a simple randomization method. This&#xD;
        study will be scheduled five times a week for six weeks. After the evaluations, all exercises&#xD;
        will be taught to the experimental group by the physiotherapist. While the experimental group&#xD;
        will apply to this program and traditional education, the control group will continue to the&#xD;
        traditional education program. Since all exercises are done with body weight, no extra&#xD;
        equipment will be needed. Reviews:&#xD;
  &#xD;
        Balance evaluation: Y balance test The Vertical Jump Test will be used to evaluate muscle&#xD;
        strength in the lower extremities.&#xD;
  &#xD;
        McGill Trunk Endurance Test: To be used for Muscular Endurance Assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</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>Parallel Assignment</intervention_model>
      <intervention_model_description>The intervention group will be given neuromuscular exercises 5 days a week for 12 weeks.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>The control group will be asked to continue the standard (routine) classical training training (5 days/12 weeks).</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Y balance test</measure>
      <time_frame>13 weeks</time_frame>
      <description>The test is a practical functional test that can predict dynamic balance and postural stability. The player's performance improves with balance, flexibility, coordination and power integration. For this test, players stand in the center of a 'Y' shaped arrangement with 3 lines drawn at certain angles. The players are asked to reach in anterior, posterolateral and posteromedial directions using one foot. Three applications are made in each direction and the average of the reach distances is recorded in centimeters. Pre-measured leg length is used to normalize the mean score of these three treatments. Percentage of maximum reach = deflection distance/leg length. Leg length; Spina iliaca anterior superior to the distal point of the medial malleolus. To obtain an overall measure of the Y Balance Test, data from all directions must be averaged to calculate the composite score.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Vertical Jump Test</measure>
      <time_frame>13 weeks</time_frame>
      <description>The Vertical Jump Test is used to evaluate muscle strength in the lower extremities. The maximum jump height reached gives information about the muscle strength and functional capacity of the lower extremities in many sports. The player keeps the feet flat on the ground. The point of the fingertips reached is recorded. This is called standing reach height. The player then begins in a stance with the knees extended, standing away from the wall, feet shoulder-width apart. After the player flexes their knees and hips, they jump up and reach the highest point they can reach with their hands. The test is performed three times and the highest distance is used as the jump height.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>McGill Body Endurance Test</measure>
      <time_frame>13 weeks</time_frame>
      <description>For trunk flexors, extensors and lateral muscles, a series of isometric tests showing the endurance of trunk muscles have been defined. The test consists of 3 parts. There is a 5-minute break between each test.&#xD;
  Tests:&#xD;
  Trunk Flexor Muscle Endurance Assessment&#xD;
  Right and Left Lateral Trunk Muscle Endurance Assessment&#xD;
  Back Extensor Muscle Endurance Evaluation</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Sports Physical Therapy</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group was asked to continue the standard (routine) classical training training (5 days/12 weeks).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>exercise group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The neuromuscular training program has been adapted to ice hockey players. The content of the program includes core stabilization, balance and plyometric exercises. The session duration was set to be approximately 60-90 minutes. An average session is 15 minutes of warm-up, followed by 30-40 minutes. continued with neuromuscular training program, 15 min. It was ended with cooling and stretching exercises. Since all exercises are done with body weight, no extra equipment is needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>exercise</intervention_name>
      <description>Exercises:&#xD;
  Lunge to Hamstrings Stretch 3 sets of 30 seconds&#xD;
  Standing Hip Out 3 sets of 30sec&#xD;
  90-90 Hip Stretch 3 sets of 30 seconds&#xD;
  World's Greatest Stretch 3 sets of 30 seconds&#xD;
  Star Excursion 3 sets of 5 reps&#xD;
  Side Jumps+ Balance 3 sets of 10 reps&#xD;
  Forward Hops + Balance 3 sets of 10 reps&#xD;
  Squat 3 sets of 10 reps&#xD;
  Squat Jump 3 sets of 10 reps&#xD;
  Jumping Spider Push-up 3 sets of 10 reps&#xD;
  Double Leg Vertical Jump 3 sets of 10 reps&#xD;
  Broad Jumps 3 sets of 10 reps&#xD;
  Lateral Box Shuffles 3 sets of 10 reps&#xD;
  Plank 3 sets of 30 seconds&#xD;
  Side Plank 3 sets of 30 seconds&#xD;
  Bird Dog 3 sets of 10 reps&#xD;
  Glute Bridge 3 sets of 10 reps&#xD;
  Single Leg Glute Bridge 3 sets of 10 reps&#xD;
  Single Toe Raises 3 sets of 30sec&#xD;
  Nordic Hamstrings 3 sets of 10 reps&#xD;
  Monster Walk 3 sets of 10 reps</description>
      <arm_group_label>exercise group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>control</intervention_name>
      <description>The control group was asked to continue the standard (routine) classical training training (5 days/12 weeks).</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being a licensed athlete of any team affiliated with the Turkish Ice Hockey Federation&#xD;
               and competing in the league,&#xD;
  &#xD;
            -  Athletes who do not use any medication and do not have a medical condition that would&#xD;
               interfere with the tests&#xD;
  &#xD;
            -  be between the ages of 15-30&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Not having had a musculoskeletal injury in the last 1 year that would prevent him from&#xD;
               training or that would affect the results of the measurements.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Merve KAPANŞAHİN</last_name>
      <role>Study Chair</role>
      <affiliation>Uskudar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ömer ŞEVGİN</last_name>
      <phone>+905069787535</phone>
      <email>omer.sevgin@uskudar.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Üsküdar Unıversıty</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ömer ŞEVGİN</last_name>
        <phone>+905069787535</phone>
        <email>omer.sevgin@uskudar.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Ransdell LB, Murray T. A physical profile of elite female ice hockey players from the USA. J Strength Cond Res. 2011 Sep;25(9):2358-63. doi: 10.1519/JSC.0b013e31822a5440.</citation>
      <PMID>21804420</PMID>
    </reference>
    <reference>
      <citation>Ronnestad BR, Ofsteng SJ, Ellefsen S. Block periodization of strength and endurance training is superior to traditional periodization in ice hockey players. Scand J Med Sci Sports. 2019 Feb;29(2):180-188. doi: 10.1111/sms.13326. Epub 2018 Nov 8.</citation>
      <PMID>30350896</PMID>
    </reference>
    <reference>
      <citation>Roczniok R, Stanula A, Maszczyk A, Mostowik A, Kowalczyk M, Fidos-Czuba O, Zajac A. Physiological, physical and on-ice performance criteria for selection of elite ice hockey teams. Biol Sport. 2016 Mar;33(1):43-8. doi: 10.5604/20831862.1180175. Epub 2015 Nov 19.</citation>
      <PMID>26985133</PMID>
    </reference>
    <reference>
      <citation>Burr JF, Jamnik RK, Baker J, Macpherson A, Gledhill N, McGuire EJ. Relationship of physical fitness test results and hockey playing potential in elite-level ice hockey players. J Strength Cond Res. 2008 Sep;22(5):1535-43. doi: 10.1519/JSC.0b013e318181ac20.</citation>
      <PMID>18714234</PMID>
    </reference>
    <reference>
      <citation>Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.</citation>
      <PMID>15722287</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Uskudar University</investigator_affiliation>
      <investigator_full_name>Dr. Öğr. Üyesi Ömer Şevgin</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <keyword>Ice hockey</keyword>
    <keyword>Neuromuscular exercise</keyword>
    <keyword>Vertical jump</keyword>
    <keyword>Trunk endurance</keyword>
    <keyword>Y balance</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998057
  org study id: Uskudar70
  nct id: NCT05998057
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to investigate the changes in dynamic balance, vertical jump and
        trunk endurance parameters in athletes included in body weight neuromuscular program in
        addition to regular training programs.
  As a randomization method, the participants will be divided into two groups as control and
        experimental groups by using a computer-based program and a simple randomization method. This
        study will be scheduled five times a week for six weeks. After the evaluations, all exercises
        will be taught to the experimental group by the physiotherapist. While the experimental group
        will apply to this program and traditional education, the control group will continue to the
        traditional education program. Since all exercises are done with body weight, no extra
        equipment will be needed. Reviews:
  
        Balance evaluation: Y balance test The Vertical Jump Test will be used to evaluate muscle
        strength in the lower extremities.
  
        McGill Trunk Endurance Test: To be used for Muscular Endurance Assessment.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The intervention group will be given neuromuscular exercises 5 days a week for 12 weeks.
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: The control group will be asked to continue the standard (routine) classical training training (5 days/12 weeks).
  measure: Y balance test
  time frame: 13 weeks
  description: The test is a practical functional test that can predict dynamic balance and postural stability. The player's performance improves with balance, flexibility, coordination and power integration. For this test, players stand in the center of a 'Y' shaped arrangement with 3 lines drawn at certain angles. The players are asked to reach in anterior, posterolateral and posteromedial directions using one foot. Three applications are made in each direction and the average of the reach distances is recorded in centimeters. Pre-measured leg length is used to normalize the mean score of these three treatments. Percentage of maximum reach = deflection distance/leg length. Leg length; Spina iliaca anterior superior to the distal point of the medial malleolus. To obtain an overall measure of the Y Balance Test, data from all directions must be averaged to calculate the composite score.
  measure: Vertical Jump Test
  time frame: 13 weeks
  description: The Vertical Jump Test is used to evaluate muscle strength in the lower extremities. The maximum jump height reached gives information about the muscle strength and functional capacity of the lower extremities in many sports. The player keeps the feet flat on the ground. The point of the fingertips reached is recorded. This is called standing reach height. The player then begins in a stance with the knees extended, standing away from the wall, feet shoulder-width apart. After the player flexes their knees and hips, they jump up and reach the highest point they can reach with their hands. The test is performed three times and the highest distance is used as the jump height.
  measure: McGill Body Endurance Test
  time frame: 13 weeks
  description: For trunk flexors, extensors and lateral muscles, a series of isometric tests showing the endurance of trunk muscles have been defined. The test consists of 3 parts. There is a 5-minute break between each test.
  Tests:
  Trunk Flexor Muscle Endurance Assessment
  Right and Left Lateral Trunk Muscle Endurance Assessment
  Back Extensor Muscle Endurance Evaluation
  arm group label: control group
  arm group type: Active Comparator
  description: The control group was asked to continue the standard (routine) classical training training (5 days/12 weeks).
  arm group label: exercise group
  arm group type: Experimental
  description: The neuromuscular training program has been adapted to ice hockey players. The content of the program includes core stabilization, balance and plyometric exercises. The session duration was set to be approximately 60-90 minutes. An average session is 15 minutes of warm-up, followed by 30-40 minutes. continued with neuromuscular training program, 15 min. It was ended with cooling and stretching exercises. Since all exercises are done with body weight, no extra equipment is needed.
  intervention type: Other
  intervention name: exercise
  description: Exercises:
  Lunge to Hamstrings Stretch 3 sets of 30 seconds
  Standing Hip Out 3 sets of 30sec
  90-90 Hip Stretch 3 sets of 30 seconds
  World's Greatest Stretch 3 sets of 30 seconds
  Star Excursion 3 sets of 5 reps
  Side Jumps+ Balance 3 sets of 10 reps
  Forward Hops + Balance 3 sets of 10 reps
  Squat 3 sets of 10 reps
  Squat Jump 3 sets of 10 reps
  Jumping Spider Push-up 3 sets of 10 reps
  Double Leg Vertical Jump 3 sets of 10 reps
  Broad Jumps 3 sets of 10 reps
  Lateral Box Shuffles 3 sets of 10 reps
  Plank 3 sets of 30 seconds
  Side Plank 3 sets of 30 seconds
  Bird Dog 3 sets of 10 reps
  Glute Bridge 3 sets of 10 reps
  Single Leg Glute Bridge 3 sets of 10 reps
  Single Toe Raises 3 sets of 30sec
  Nordic Hamstrings 3 sets of 10 reps
  Monster Walk 3 sets of 10 reps
  arm group label: exercise group
  intervention type: Other
  intervention name: control
  description: The control group was asked to continue the standard (routine) classical training training (5 days/12 weeks).
  arm group label: control group
  criteria: 
  gender: Female
  minimum age: 15 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Merve KAPANŞAHİN
  role: Study Chair
  affiliation: Uskudar University
  last name: Ömer ŞEVGİN
  phone: +905069787535
  email: omer.sevgin@uskudar.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Ransdell LB, Murray T. A physical profile of elite female ice hockey players from the USA. J Strength Cond Res. 2011 Sep;25(9):2358-63. doi: 10.1519/JSC.0b013e31822a5440.
  PMID: 21804420
  citation: Ronnestad BR, Ofsteng SJ, Ellefsen S. Block periodization of strength and endurance training is superior to traditional periodization in ice hockey players. Scand J Med Sci Sports. 2019 Feb;29(2):180-188. doi: 10.1111/sms.13326. Epub 2018 Nov 8.
  PMID: 30350896
  citation: Roczniok R, Stanula A, Maszczyk A, Mostowik A, Kowalczyk M, Fidos-Czuba O, Zajac A. Physiological, physical and on-ice performance criteria for selection of elite ice hockey teams. Biol Sport. 2016 Mar;33(1):43-8. doi: 10.5604/20831862.1180175. Epub 2015 Nov 19.
  PMID: 26985133
  citation: Burr JF, Jamnik RK, Baker J, Macpherson A, Gledhill N, McGuire EJ. Relationship of physical fitness test results and hockey playing potential in elite-level ice hockey players. J Strength Cond Res. 2008 Sep;22(5):1535-43. doi: 10.1519/JSC.0b013e318181ac20.
  PMID: 18714234
  citation: Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
  PMID: 15722287
  responsible party type: Principal Investigator
  investigator affiliation: Uskudar University
  investigator full name: Dr. Öğr. Üyesi Ömer Şevgin
  investigator title: assistant professor
  sharing ipd: No