<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/NCT04459195</url>
  </required_header>
  <id_info>
    <org_study_id>Kamile U Akkaya</org_study_id>
    <nct_id>NCT04459195</nct_id>
  </id_info>
  <brief_title>Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization</brief_title>
  <official_title>An Investigation of Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization by Superb Microvascular Imaging Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuksek Ihtisas University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuksek Ihtisas University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim&#xD;
      of our study is to examine the acute effects of static stretching duration on gastrocnemius&#xD;
      muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to&#xD;
      compare the effects of 2 and 5 minutes of static stretching on blood flow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be included 30 healthy volunteers. The participants will be divided into two&#xD;
      groups. Static stretching was administered to the gastrocnemius muscle. Stretching&#xD;
      applications will be applied to the first group for 2 minutes and to the second group for 5&#xD;
      minutes. Muscle vascularization will be evaluated by a new method, superb microvascular&#xD;
      imaging (SMI). SMI is a recently developed ultrasound imaging technique that aims to&#xD;
      visualize low velocity and small diameter blood vessel flow.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Actual">August 7, 2020</completion_date>
  <primary_completion_date type="Actual">August 7, 2020</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle vascularization</measure>
    <time_frame>Immediately after the application.</time_frame>
    <description>The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle vascularization</measure>
    <time_frame>10 minutes after the application.</time_frame>
    <description>The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Muscle Stretching Exercises</condition>
  <arm_group>
    <arm_group_label>2 Minute Static stretching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stretching applications will be applied to the first group for 2 minutes .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 Minute Static stretching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stretching applications will be applied to the first group for 5 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>2 Minute Static Stretching</intervention_name>
    <description>Stretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.</description>
    <arm_group_label>2 Minute Static stretching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>5 Minute Static Stretching</intervention_name>
    <description>Stretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.</description>
    <arm_group_label>5 Minute Static stretching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers between the ages of 18-35,&#xD;
&#xD;
          -  Without knee, hip, ankle and waist pathology,&#xD;
&#xD;
          -  Has not undergone any surgery on the lower extremity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rheumatic, musculoskeletal, neurological and vestibular problems,&#xD;
&#xD;
          -  Bone pathologies,&#xD;
&#xD;
          -  Joint laxity,&#xD;
&#xD;
          -  Connective tissue disorders&#xD;
&#xD;
          -  Diabetes, metabolic syndrome, arthritic or inflammatory problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yuksek Ihtisas University</name>
      <address>
        <city>Ankara</city>
        <zip>06520</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://radiopaedia.org/articles/superb-microvascular-imaging-ultrasound</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Caliskan E, Akkoc O, Bayramoglu Z, Gozubuyuk OB, Kural D, Azamat S, Adaletli I. Effects of static stretching duration on muscle stiffness and blood flow in the rectus femoris in adolescents. Med Ultrason. 2019 May 2;21(2):136-143. doi: 10.11152/mu-1859.</citation>
    <PMID>31063516</PMID>
  </reference>
  <reference>
    <citation>Maeda N, Urabe Y, Tsutsumi S, Sakai S, Fujishita H, Kobayashi T, Asaeda M, Hirata K, Mikami Y, Kimura H. The Acute Effects of Static and Cyclic Stretching on Muscle Stiffness and Hardness of Medial Gastrocnemius Muscle. J Sports Sci Med. 2017 Dec 1;16(4):514-520. eCollection 2017 Dec.</citation>
    <PMID>29238251</PMID>
  </reference>
  <reference>
    <citation>Nakamura M, Ikezoe T, Nishishita S, Umehara J, Kimura M, Ichihashi N. Acute effects of static stretching on the shear elastic moduli of the medial and lateral gastrocnemius muscles in young and elderly women. Musculoskelet Sci Pract. 2017 Dec;32:98-103. doi: 10.1016/j.msksp.2017.09.006. Epub 2017 Sep 25.</citation>
    <PMID>28988152</PMID>
  </reference>
  <reference>
    <citation>Jiang ZZ, Huang YH, Shen HL, Liu XT. Clinical Applications of Superb Microvascular Imaging in the Liver, Breast, Thyroid, Skeletal Muscle, and Carotid Plaques. J Ultrasound Med. 2019 Nov;38(11):2811-2820. doi: 10.1002/jum.15008. Epub 2019 Apr 5.</citation>
    <PMID>30953387</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>December 22, 2020</last_update_submitted>
  <last_update_submitted_qc>December 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuksek Ihtisas University</investigator_affiliation>
    <investigator_full_name>Kamile UZUN AKKAYA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gastrocnemius</keyword>
  <keyword>Static Stretching</keyword>
  <keyword>Muscle Vascularization</keyword>
  <keyword>Superb Microvascular Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neovascularization, Pathologic</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/NCT04459195
org study id: Kamile U Akkaya
nct id: NCT04459195
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim
      of our study is to examine the acute effects of static stretching duration on gastrocnemius
      muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to
      compare the effects of 2 and 5 minutes of static stretching on blood flow.
The study will be included 30 healthy volunteers. The participants will be divided into two
      groups. Static stretching was administered to the gastrocnemius muscle. Stretching
      applications will be applied to the first group for 2 minutes and to the second group for 5
      minutes. Muscle vascularization will be evaluated by a new method, superb microvascular
      imaging (SMI). SMI is a recently developed ultrasound imaging technique that aims to
      visualize low velocity and small diameter blood vessel flow.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Muscle vascularization
time frame: Immediately after the application.
description: The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
measure: Muscle vascularization
time frame: 10 minutes after the application.
description: The evaluation of muscle vascularization will be made using the Superb microvascular imaging method by a radiologist. Superb microvascular imaging is a recently developed ultrasound imaging technique that aims to visualize low velocity and small diameter blood vessel flow.
arm group label: 2 Minute Static stretching
arm group type: Experimental
description: Stretching applications will be applied to the first group for 2 minutes .
arm group label: 5 Minute Static stretching
arm group type: Experimental
description: Stretching applications will be applied to the first group for 5 minutes.
intervention type: Behavioral
intervention name: 2 Minute Static Stretching
description: Stretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
arm group label: 2 Minute Static stretching
intervention type: Behavioral
intervention name: 5 Minute Static Stretching
description: Stretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
arm group label: 5 Minute Static stretching
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
url: http://radiopaedia.org/articles/superb-microvascular-imaging-ultrasound
description: Related Info
citation: Caliskan E, Akkoc O, Bayramoglu Z, Gozubuyuk OB, Kural D, Azamat S, Adaletli I. Effects of static stretching duration on muscle stiffness and blood flow in the rectus femoris in adolescents. Med Ultrason. 2019 May 2;21(2):136-143. doi: 10.11152/mu-1859.
PMID: 31063516
citation: Maeda N, Urabe Y, Tsutsumi S, Sakai S, Fujishita H, Kobayashi T, Asaeda M, Hirata K, Mikami Y, Kimura H. The Acute Effects of Static and Cyclic Stretching on Muscle Stiffness and Hardness of Medial Gastrocnemius Muscle. J Sports Sci Med. 2017 Dec 1;16(4):514-520. eCollection 2017 Dec.
PMID: 29238251
citation: Nakamura M, Ikezoe T, Nishishita S, Umehara J, Kimura M, Ichihashi N. Acute effects of static stretching on the shear elastic moduli of the medial and lateral gastrocnemius muscles in young and elderly women. Musculoskelet Sci Pract. 2017 Dec;32:98-103. doi: 10.1016/j.msksp.2017.09.006. Epub 2017 Sep 25.
PMID: 28988152
citation: Jiang ZZ, Huang YH, Shen HL, Liu XT. Clinical Applications of Superb Microvascular Imaging in the Liver, Breast, Thyroid, Skeletal Muscle, and Carotid Plaques. J Ultrasound Med. 2019 Nov;38(11):2811-2820. doi: 10.1002/jum.15008. Epub 2019 Apr 5.
PMID: 30953387
responsible party type: Principal Investigator
investigator affiliation: Yuksek Ihtisas University
investigator full name: Kamile UZUN AKKAYA
investigator title: Principal Investigator
mesh term: Neovascularization, Pathologic
sharing ipd: Undecided