<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/NCT03750799</url>
  </required_header>
  <id_info>
    <org_study_id>IstPMRTRH-BMR2</org_study_id>
    <nct_id>NCT03750799</nct_id>
  </id_info>
  <brief_title>Cross-training Effect of Whole-body Vibration</brief_title>
  <acronym>CTEWBW</acronym>
  <official_title>Cross-training Effect of Whole-body Vibration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</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>
      This study evaluates whether an increase in the ipsilateral knee flexor muscle strength&#xD;
      transfers to the contralateral knee extensors which are not exposed to vibration, when&#xD;
      unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half&#xD;
      of volunteers the right leg were exposed vibration, while in the other half the right leg&#xD;
      were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts,&#xD;
      USA) extremity-testing system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was included 40 healthy volunteers. The change in the quadriceps muscle strength&#xD;
      after 20 session of WBV exercises was evaluated this study. In the WBV group, 20 sessions of&#xD;
      unilateral lower extremity vibration exercises were performed with the Whole Body Vibration&#xD;
      (WBV) device. WBV was applied when the subjects are in the semi-squat position. WBV was&#xD;
      implemented with Powerplate® Pro5 (PowerPlate® International Ltd, London, United Kingdom).&#xD;
      During 20 sessions, the WBV amplitude and vibration time were increased gradually. In the&#xD;
      first session, the subjects were do a 30-second, 30-35, 40- and 45-Hz low-amplitude WBV while&#xD;
      the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second&#xD;
      rest period between vibration applications were applied. A total duration of WBV was be two&#xD;
      minutes. In the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-Hz&#xD;
      high-amplitude WBV while the knee and hip joint were in 45 degrees of flexion; 10-second rest&#xD;
      period between vibration applications were applied. A total duration of WBV was eight&#xD;
      minutes. During WBV, the left lower extremity was in the knee-hip flexion position but was&#xD;
      not exposed the vibration.&#xD;
&#xD;
      The same experimental protocol was applied to the isometric exercise (control) group. Unlike&#xD;
      the experimental group, sham vibration was applied to the control group. Before and after 20&#xD;
      session-exercise, both knee extensor isokinetic muscle strength was measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 12, 2018</start_date>
  <completion_date type="Actual">February 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Experimental group was exposed WBV, Control group was exposed sham WBV</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>All of the participants were told that the vibration stimulation was performed for muscle strengthening. However, participants had no knowledge about the characteristics of the vibration used for muscle-strength enhancement. Vibration was applied in the experimental group, whereas sham vibration was applied in the Control group. The WBV exercise was performed at different days for the Control and Experimental groups to make them blind to each other's applications.All measurements were made by an independent assessor (isokinetic test laboratory assistant) blinded to the trial allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle strength gain of the untrained contralateral quadriceps muscle</measure>
    <time_frame>four months</time_frame>
    <description>Untrained contralateral quadriceps muscle strength was measured with the Cybex extremity-testing system before and after trial. Unit of this parameter was Nm</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Muscle Physiology</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Whole body vibration was applied on the right lower extremity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Unlike the experimental group, sham vibration was applied to the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Whole body vibration</intervention_name>
    <description>Whole body vibration was applied on the right lower extremity in the experimental group.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham vibration</intervention_name>
    <description>Sham vibration was applied on the right lower extremity in the Control sham group</description>
    <arm_group_label>Sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men with ages between 20-50 years&#xD;
&#xD;
          -  Being healthy&#xD;
&#xD;
          -  Being volunteer&#xD;
&#xD;
          -  Right-sided dominant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-cooperative subject&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ilhan Karacan, Assoc Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.</citation>
    <PMID>28457998</PMID>
  </reference>
  <reference>
    <citation>Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.</citation>
    <PMID>27485766</PMID>
  </reference>
  <reference>
    <citation>Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Turker KS. Whole-body vibration-induced muscular reflex: Is it a stretch-induced reflex? J Phys Ther Sci. 2015 Jul;27(7):2279-84. doi: 10.1589/jpts.27.2279. Epub 2015 Jul 22.</citation>
    <PMID>26310784</PMID>
  </reference>
  <reference>
    <citation>Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.</citation>
    <PMID>25551934</PMID>
  </reference>
  <reference>
    <citation>Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.</citation>
    <PMID>25207162</PMID>
  </reference>
  <reference>
    <citation>Cakar HI, Cidem M, Kara S, Karacan I. Vibration paradox and H-reflex suppression: is H-reflex suppression results from distorting effect of vibration? J Musculoskelet Neuronal Interact. 2014 Sep;14(3):318-24.</citation>
    <PMID>25198227</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Physical Medicine Rehabilitation Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Ilhan KARACAN</investigator_full_name>
    <investigator_title>Researcher, Assoc Prof</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03750799
org study id: IstPMRTRH-BMR2
nct id: NCT03750799
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates whether an increase in the ipsilateral knee flexor muscle strength
      transfers to the contralateral knee extensors which are not exposed to vibration, when
      unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half
      of volunteers the right leg were exposed vibration, while in the other half the right leg
      were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts,
      USA) extremity-testing system.
This study was included 40 healthy volunteers. The change in the quadriceps muscle strength
      after 20 session of WBV exercises was evaluated this study. In the WBV group, 20 sessions of
      unilateral lower extremity vibration exercises were performed with the Whole Body Vibration
      (WBV) device. WBV was applied when the subjects are in the semi-squat position. WBV was
      implemented with Powerplate® Pro5 (PowerPlate® International Ltd, London, United Kingdom).
      During 20 sessions, the WBV amplitude and vibration time were increased gradually. In the
      first session, the subjects were do a 30-second, 30-35, 40- and 45-Hz low-amplitude WBV while
      the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second
      rest period between vibration applications were applied. A total duration of WBV was be two
      minutes. In the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-Hz
      high-amplitude WBV while the knee and hip joint were in 45 degrees of flexion; 10-second rest
      period between vibration applications were applied. A total duration of WBV was eight
      minutes. During WBV, the left lower extremity was in the knee-hip flexion position but was
      not exposed the vibration.

      The same experimental protocol was applied to the isometric exercise (control) group. Unlike
      the experimental group, sham vibration was applied to the control group. Before and after 20
      session-exercise, both knee extensor isokinetic muscle strength was measured.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Experimental group was exposed WBV, Control group was exposed sham WBV
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: All of the participants were told that the vibration stimulation was performed for muscle strengthening. However, participants had no knowledge about the characteristics of the vibration used for muscle-strength enhancement. Vibration was applied in the experimental group, whereas sham vibration was applied in the Control group. The WBV exercise was performed at different days for the Control and Experimental groups to make them blind to each other's applications.All measurements were made by an independent assessor (isokinetic test laboratory assistant) blinded to the trial allocation.
measure: Muscle strength gain of the untrained contralateral quadriceps muscle
time frame: four months
description: Untrained contralateral quadriceps muscle strength was measured with the Cybex extremity-testing system before and after trial. Unit of this parameter was Nm
arm group label: Experimental group
arm group type: Experimental
description: Whole body vibration was applied on the right lower extremity.
arm group label: Sham group
arm group type: Sham Comparator
description: Unlike the experimental group, sham vibration was applied to the control group.
intervention type: Device
intervention name: Whole body vibration
description: Whole body vibration was applied on the right lower extremity in the experimental group.
arm group label: Experimental group
intervention type: Device
intervention name: Sham vibration
description: Sham vibration was applied on the right lower extremity in the Control sham group
arm group label: Sham group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ilhan Karacan, Assoc Prof
role: Study Chair
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
facility: 
country: Turkey
citation: Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.
PMID: 28457998
citation: Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.
PMID: 27485766
citation: Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Turker KS. Whole-body vibration-induced muscular reflex: Is it a stretch-induced reflex? J Phys Ther Sci. 2015 Jul;27(7):2279-84. doi: 10.1589/jpts.27.2279. Epub 2015 Jul 22.
PMID: 26310784
citation: Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.
PMID: 25551934
citation: Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
PMID: 25207162
citation: Cakar HI, Cidem M, Kara S, Karacan I. Vibration paradox and H-reflex suppression: is H-reflex suppression results from distorting effect of vibration? J Musculoskelet Neuronal Interact. 2014 Sep;14(3):318-24.
PMID: 25198227
responsible party type: Principal Investigator
investigator affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
investigator full name: Ilhan KARACAN
investigator title: Researcher, Assoc Prof
sharing ipd: No