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/NCT05991999</url>
    </required_header>
    <id_info>
      <org_study_id>SYeditepe</org_study_id>
      <nct_id>NCT05991999</nct_id>
    </id_info>
    <brief_title>The Effect of Stretching of Swimming-related Muscles on 800-meter Swimming Performance in Master Swimmers.</brief_title>
    <official_title>The Effect of Stretching The Pectoralis Major, Sternocleidomastoid, and Iliopsoas Muscles on 800 Meters Swimming Performance in Master Swimmers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yeditepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yeditepe 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 study aimed to investigate the effect of stretching the sternocleidomastoid, pectoralis&#xD;
        major and iliopsoas muscles on 800 meters freestyle swimming performance in master swimmers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The benefits of swimming are almost endless. Swimming is important not only as a sport but&#xD;
        also for evaluating leisure time, building strength, and recuperating. It even allows some&#xD;
        muscles to grow symmetrically and consistently. There is no malfunctioning muscle group in&#xD;
        swimming. Even when swimming with minimal effort, one can move with relatively little force&#xD;
        and easily. Besides this, it establishes a sense of trust.&#xD;
  &#xD;
        Sportive swimming is described as the athlete's ability to complete specific distances in&#xD;
        water in the quickest amount of time using freestyle, backstroke, breaststroke, or butterfly&#xD;
        strokes. The backstroke technique is performed in supine posture, while the other techniques&#xD;
        are swum in facedown, horizontal, and near-horizontal positions. Variable approaches have&#xD;
        varied characteristics in terms of body position, leg kick, arm pulling, head position,&#xD;
        respiration, and condition.&#xD;
  &#xD;
        Biomechanically, our myofascial connections also helps swimmers while they swim. Tightening&#xD;
        Superficial Front Line (SFL) causes flexion of the hips and trunk in motion also produces&#xD;
        hyperextension at the top of the neck. The large muscles of the pectoralis and latissimus&#xD;
        provide the motive force for the large movements of adduction and extension, such as a&#xD;
        swimming stroke. Vertical fibers in the fascia on the profound side of the epimysium of the&#xD;
        pectoralis major, which does indeed connect from the rectus attachment to the lower part of&#xD;
        the fascia colli superficialis (and sternocleidomastoid (SCM)). Lower extremity also&#xD;
        coordinates stability while upper part of the body initiates movements between phases&#xD;
        İliopsoas starts the hip flexion and is followed up by the rectus femoris initiates knee&#xD;
        extension to continue horizontal movement in the water.&#xD;
  &#xD;
        Because of the demands of the sport, swimmers have a more rounded forward posture. When the&#xD;
        head is forward, the cervical spine is hyperextended, the thoracic spine is in slight&#xD;
        flexion, and the lumbar spine is in slight extension, this is known as forward posture.&#xD;
        Muscle imbalances in the shoulders are to blame for this forward posture. In the recovery&#xD;
        phase of swimming, the scapula must retract and protract along the thoracic wall. The&#xD;
        subacromial space reduces with protraction because of the swimmer's adaptation due to sport.&#xD;
        Stretching the scapular protractors such as the pectoralis major muscle has been shown to&#xD;
        have a considerable impact on the degree of forwarding shoulder posture (FSP) in healthy&#xD;
        people. Besides this adaptation also, swimmers with shoulder pain because of more active&#xD;
        trigger points can lead to the development of mechanical hypersensitivity compared to ones&#xD;
        that do not have any shoulder pain.&#xD;
  &#xD;
        As summarized above, swimming athletes generally have a forward posture due to their&#xD;
        adaptation to water. In our opinion, this posture may be due to the tension of the anterior&#xD;
        group myofascial structures, and releasing the fascia by stretching might affect swimmers'&#xD;
        performance. Master swimmers have that adaptation far more compared to young swimmers.&#xD;
        Therefore, we can better observe the effects of Sternocleidomastoid, Pectoralis major, and&#xD;
        İliopsoas muscle stretching on swimming performance by testing swimmers at distances such as&#xD;
        800 meters.&#xD;
  &#xD;
        H0: There is no significant difference between the 800-meter performance measurements of the&#xD;
        people in the group that added stretching of specific muscles to their normal training and&#xD;
        those in the group that did not add stretching.&#xD;
  &#xD;
        H1: There is a significant difference in the 800-meter performance measurements of the group&#xD;
        with specific muscle stretching added to their normal training and the people in the group&#xD;
        without stretching.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">August 5, 2023</start_date>
    <completion_date type="Anticipated">September 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 15, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>800 Meter Degree test</measure>
      <time_frame>6 weeks</time_frame>
      <description>The 800 meter test will be used to evaluate the long-term aerobic metabolic performance of master swimmers.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The MyotonPro - Frequency</measure>
      <time_frame>6 weeks</time_frame>
      <description>The tone of muscle is described by frequency of muscle or oscillation frequency (Hz). It evaluates the tone that the muscle is at resting position.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The MyotonPro - Stiffness</measure>
      <time_frame>6 weeks</time_frame>
      <description>Stiffness is biomechanical feature of a muscle. It is described by reaction to contraction or forces from outside of tissue that may cause the original form to deteriorate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The MyotonPro - Decrement</measure>
      <time_frame>6 weeks</time_frame>
      <description>The elasticity of a muscle is described by a logarithmic reduction of tissue's normal amplitude. It is more related with the dissipation of mechanical energy that arises between the deformation of the tissue and its recovery. It is a biomechanical feature of tissue that is called as elasticity. When the tissue's decrement is increase, elasticity decreases. There is an opposite proportion among themselves.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The MyotonPro - Relaxation</measure>
      <time_frame>6 weeks</time_frame>
      <description>It is the time which is called as Mechanical Stress Relaxation Time (ms) between the deformation of the normal shape of the tissue and its return to its original shape.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The MyotonPro - Creep</measure>
      <time_frame>6 weeks</time_frame>
      <description>It is defined as ratio of deterioration and relaxation time of tissue. In case of a continuous stress, tissue regularly stretches over time. This is called as creep.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Stretch</condition>
    <arm_group>
      <arm_group_label>The Study Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>800-meter swimming performance tests were administered to all swimmers prior to the measurement. The study group started to do stretch exercises every day for 6 weeks. At the end of six weeks, performance tests and myoton measurements were administered and analyzed for both groups.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>800-meter swimming performance tests were administered to all swimmers prior to the measurement. The control group just continued their regular training for 6 weeks. At the end of six weeks, performance tests and myoton measurements were administered and analyzed for both groups.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Stretching</intervention_name>
      <description>Master swimmers will be taught iliopsoas, sternocleidomastoid and pectoralis major stretching exercises as stretching exercises. Participants will stretch daily for 3 repetitions, each stretching for 20 seconds.&#xD;
  Participants will continue their swimming training 2 days a week.</description>
      <arm_group_label>The Study Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Training</intervention_name>
      <description>Participants continued their swimming training 2 days a week.</description>
      <arm_group_label>The Control Group</arm_group_label>
      <arm_group_label>The Study Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants in the study voluntarily,&#xD;
  &#xD;
            -  Participants in ages over 25 years of age,&#xD;
  &#xD;
            -  Participants must swim at least two days a week.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of chronic disease,&#xD;
  &#xD;
            -  Participants have undergone surgery in relevant regions in the last 2 years,&#xD;
  &#xD;
            -  Participants have had injuries in the relevant regions in the last 2 years.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Şafak Özsönmez</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yeditepe University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Yeditepe University</name>
        <address>
          <city>Istanbul</city>
          <state>Ataşehir/İstanbul</state>
          <zip>34755</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <link>
      <url>https://www.myoton.com/applications</url>
      <description>Applications - Myoton. Accessed June 28, 2023</description>
    </link>
    <reference>
      <citation>Rittweger J, Kwiet A, Felsenberg D. Physical performance in aging elite athletes--challenging the limits of physiology. J Musculoskelet Neuronal Interact. 2004 Jun;4(2):159-60. No abstract available.</citation>
      <PMID>15615117</PMID>
    </reference>
    <reference>
      <citation>Tanaka H, Seals DR. Endurance exercise performance in Masters athletes: age-associated changes and underlying physiological mechanisms. J Physiol. 2008 Jan 1;586(1):55-63. doi: 10.1113/jphysiol.2007.141879. Epub 2007 Aug 23.</citation>
      <PMID>17717011</PMID>
    </reference>
    <reference>
      <citation>Rubin RT, Rahe RH. Effects of aging in Masters swimmers: 40-year review and suggestions for optimal health benefits. Open Access J Sports Med. 2010 Apr 7;1:39-44. doi: 10.2147/oajsm.s9315.</citation>
      <PMID>24198541</PMID>
    </reference>
    <reference>
      <citation>Batalha NM, Raimundo AM, Tomas-Carus P, Barbosa TM, Silva AJ. Shoulder rotator cuff balance, strength, and endurance in young swimmers during a competitive season. J Strength Cond Res. 2013 Sep;27(9):2562-8. doi: 10.1519/JSC.0b013e31827fd849.</citation>
      <PMID>23249824</PMID>
    </reference>
    <reference>
      <citation>Solem-Bertoft E, Thuomas KA, Westerberg CE. The influence of scapular retraction and protraction on the width of the subacromial space. An MRI study. Clin Orthop Relat Res. 1993 Nov;(296):99-103.</citation>
      <PMID>8222458</PMID>
    </reference>
    <reference>
      <citation>Klingler W, Velders M, Hoppe K, Pedro M, Schleip R. Clinical relevance of fascial tissue and dysfunctions. Curr Pain Headache Rep. 2014;18(8):439. doi: 10.1007/s11916-014-0439-y.</citation>
      <PMID>24962403</PMID>
    </reference>
    <reference>
      <citation>Findley T, Chaudhry H, Stecco A, Roman M. Fascia research--a narrative review. J Bodyw Mov Ther. 2012 Jan;16(1):67-75. doi: 10.1016/j.jbmt.2011.09.004. Erratum In: J Bodyw Mov Ther. 2012 Apr;16(2):270.</citation>
      <PMID>22196430</PMID>
    </reference>
    <reference>
      <citation>Hidalgo-Lozano A, Fernandez-de-las-Penas C, Calderon-Soto C, Domingo-Camara A, Madeleine P, Arroyo-Morales M. Elite swimmers with and without unilateral shoulder pain: mechanical hyperalgesia and active/latent muscle trigger points in neck-shoulder muscles. Scand J Med Sci Sports. 2013 Feb;23(1):66-73. doi: 10.1111/j.1600-0838.2011.01331.x. Epub 2011 May 12.</citation>
      <PMID>21564310</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 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>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Master swimmer</keyword>
    <keyword>Swimming</keyword>
    <keyword>Stretching</keyword>
    <keyword>800 meter</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/NCT05991999
  org study id: SYeditepe
  nct id: NCT05991999
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study aimed to investigate the effect of stretching the sternocleidomastoid, pectoralis
        major and iliopsoas muscles on 800 meters freestyle swimming performance in master swimmers.
  The benefits of swimming are almost endless. Swimming is important not only as a sport but
        also for evaluating leisure time, building strength, and recuperating. It even allows some
        muscles to grow symmetrically and consistently. There is no malfunctioning muscle group in
        swimming. Even when swimming with minimal effort, one can move with relatively little force
        and easily. Besides this, it establishes a sense of trust.
  
        Sportive swimming is described as the athlete's ability to complete specific distances in
        water in the quickest amount of time using freestyle, backstroke, breaststroke, or butterfly
        strokes. The backstroke technique is performed in supine posture, while the other techniques
        are swum in facedown, horizontal, and near-horizontal positions. Variable approaches have
        varied characteristics in terms of body position, leg kick, arm pulling, head position,
        respiration, and condition.
  
        Biomechanically, our myofascial connections also helps swimmers while they swim. Tightening
        Superficial Front Line (SFL) causes flexion of the hips and trunk in motion also produces
        hyperextension at the top of the neck. The large muscles of the pectoralis and latissimus
        provide the motive force for the large movements of adduction and extension, such as a
        swimming stroke. Vertical fibers in the fascia on the profound side of the epimysium of the
        pectoralis major, which does indeed connect from the rectus attachment to the lower part of
        the fascia colli superficialis (and sternocleidomastoid (SCM)). Lower extremity also
        coordinates stability while upper part of the body initiates movements between phases
        İliopsoas starts the hip flexion and is followed up by the rectus femoris initiates knee
        extension to continue horizontal movement in the water.
  
        Because of the demands of the sport, swimmers have a more rounded forward posture. When the
        head is forward, the cervical spine is hyperextended, the thoracic spine is in slight
        flexion, and the lumbar spine is in slight extension, this is known as forward posture.
        Muscle imbalances in the shoulders are to blame for this forward posture. In the recovery
        phase of swimming, the scapula must retract and protract along the thoracic wall. The
        subacromial space reduces with protraction because of the swimmer's adaptation due to sport.
        Stretching the scapular protractors such as the pectoralis major muscle has been shown to
        have a considerable impact on the degree of forwarding shoulder posture (FSP) in healthy
        people. Besides this adaptation also, swimmers with shoulder pain because of more active
        trigger points can lead to the development of mechanical hypersensitivity compared to ones
        that do not have any shoulder pain.
  
        As summarized above, swimming athletes generally have a forward posture due to their
        adaptation to water. In our opinion, this posture may be due to the tension of the anterior
        group myofascial structures, and releasing the fascia by stretching might affect swimmers'
        performance. Master swimmers have that adaptation far more compared to young swimmers.
        Therefore, we can better observe the effects of Sternocleidomastoid, Pectoralis major, and
        İliopsoas muscle stretching on swimming performance by testing swimmers at distances such as
        800 meters.
  
        H0: There is no significant difference between the 800-meter performance measurements of the
        people in the group that added stretching of specific muscles to their normal training and
        those in the group that did not add stretching.
  
        H1: There is a significant difference in the 800-meter performance measurements of the group
        with specific muscle stretching added to their normal training and the people in the group
        without stretching.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: 800 Meter Degree test
  time frame: 6 weeks
  description: The 800 meter test will be used to evaluate the long-term aerobic metabolic performance of master swimmers.
  measure: The MyotonPro - Frequency
  time frame: 6 weeks
  description: The tone of muscle is described by frequency of muscle or oscillation frequency (Hz). It evaluates the tone that the muscle is at resting position.
  measure: The MyotonPro - Stiffness
  time frame: 6 weeks
  description: Stiffness is biomechanical feature of a muscle. It is described by reaction to contraction or forces from outside of tissue that may cause the original form to deteriorate.
  measure: The MyotonPro - Decrement
  time frame: 6 weeks
  description: The elasticity of a muscle is described by a logarithmic reduction of tissue's normal amplitude. It is more related with the dissipation of mechanical energy that arises between the deformation of the tissue and its recovery. It is a biomechanical feature of tissue that is called as elasticity. When the tissue's decrement is increase, elasticity decreases. There is an opposite proportion among themselves.
  measure: The MyotonPro - Relaxation
  time frame: 6 weeks
  description: It is the time which is called as Mechanical Stress Relaxation Time (ms) between the deformation of the normal shape of the tissue and its return to its original shape.
  measure: The MyotonPro - Creep
  time frame: 6 weeks
  description: It is defined as ratio of deterioration and relaxation time of tissue. In case of a continuous stress, tissue regularly stretches over time. This is called as creep.
  arm group label: The Study Group
  arm group type: Experimental
  description: 800-meter swimming performance tests were administered to all swimmers prior to the measurement. The study group started to do stretch exercises every day for 6 weeks. At the end of six weeks, performance tests and myoton measurements were administered and analyzed for both groups.
  arm group label: The Control Group
  arm group type: Active Comparator
  description: 800-meter swimming performance tests were administered to all swimmers prior to the measurement. The control group just continued their regular training for 6 weeks. At the end of six weeks, performance tests and myoton measurements were administered and analyzed for both groups.
  intervention type: Other
  intervention name: Stretching
  description: Master swimmers will be taught iliopsoas, sternocleidomastoid and pectoralis major stretching exercises as stretching exercises. Participants will stretch daily for 3 repetitions, each stretching for 20 seconds.
  Participants will continue their swimming training 2 days a week.
  arm group label: The Study Group
  intervention type: Other
  intervention name: Training
  description: Participants continued their swimming training 2 days a week.
  arm group label: The Control Group
  arm group label: The Study Group
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 25 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Şafak Özsönmez
  role: Principal Investigator
  affiliation: Yeditepe University
  facility: 
  country: Turkey
  url: https://www.myoton.com/applications
  description: Applications - Myoton. Accessed June 28, 2023
  citation: Rittweger J, Kwiet A, Felsenberg D. Physical performance in aging elite athletes--challenging the limits of physiology. J Musculoskelet Neuronal Interact. 2004 Jun;4(2):159-60. No abstract available.
  PMID: 15615117
  citation: Tanaka H, Seals DR. Endurance exercise performance in Masters athletes: age-associated changes and underlying physiological mechanisms. J Physiol. 2008 Jan 1;586(1):55-63. doi: 10.1113/jphysiol.2007.141879. Epub 2007 Aug 23.
  PMID: 17717011
  citation: Rubin RT, Rahe RH. Effects of aging in Masters swimmers: 40-year review and suggestions for optimal health benefits. Open Access J Sports Med. 2010 Apr 7;1:39-44. doi: 10.2147/oajsm.s9315.
  PMID: 24198541
  citation: Batalha NM, Raimundo AM, Tomas-Carus P, Barbosa TM, Silva AJ. Shoulder rotator cuff balance, strength, and endurance in young swimmers during a competitive season. J Strength Cond Res. 2013 Sep;27(9):2562-8. doi: 10.1519/JSC.0b013e31827fd849.
  PMID: 23249824
  citation: Solem-Bertoft E, Thuomas KA, Westerberg CE. The influence of scapular retraction and protraction on the width of the subacromial space. An MRI study. Clin Orthop Relat Res. 1993 Nov;(296):99-103.
  PMID: 8222458
  citation: Klingler W, Velders M, Hoppe K, Pedro M, Schleip R. Clinical relevance of fascial tissue and dysfunctions. Curr Pain Headache Rep. 2014;18(8):439. doi: 10.1007/s11916-014-0439-y.
  PMID: 24962403
  citation: Findley T, Chaudhry H, Stecco A, Roman M. Fascia research--a narrative review. J Bodyw Mov Ther. 2012 Jan;16(1):67-75. doi: 10.1016/j.jbmt.2011.09.004. Erratum In: J Bodyw Mov Ther. 2012 Apr;16(2):270.
  PMID: 22196430
  citation: Hidalgo-Lozano A, Fernandez-de-las-Penas C, Calderon-Soto C, Domingo-Camara A, Madeleine P, Arroyo-Morales M. Elite swimmers with and without unilateral shoulder pain: mechanical hyperalgesia and active/latent muscle trigger points in neck-shoulder muscles. Scand J Med Sci Sports. 2013 Feb;23(1):66-73. doi: 10.1111/j.1600-0838.2011.01331.x. Epub 2011 May 12.
  PMID: 21564310
  responsible party type: Sponsor
  sharing ipd: No