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/NCT06017245</url>
    </required_header>
    <id_info>
      <org_study_id>BMROPS</org_study_id>
      <nct_id>NCT06017245</nct_id>
    </id_info>
    <brief_title>The Bone-Myoregulation Reflex and Development of Sarcopenia in Osteoporosis</brief_title>
    <official_title>Could the Bone-Myoregulation Reflex Explain the Development of Sarcopenia in Postmenopausal and Senile Osteoporosis?</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>
        Bone and skeletal muscle are in a single unit that interacts with each other structurally and&#xD;
        functionally. The aim of this study is to determine the contribution of bone myoregulation&#xD;
        reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal&#xD;
        and senile osteoporosis&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bone and skeletal muscle are in a single unit that interacts with each other structurally and&#xD;
        functionally. While myokines synthesized and released in skeletal muscle modulate the bone&#xD;
        formation and destruction process, osteokines synthesized and released by bone cells have&#xD;
        positive or negative effects on muscle (4,5,6,7,8,9). In addition to humoral crosstalk&#xD;
        mechanisms between muscle and bone, there is also a neuronal crosstalk mechanism defined as&#xD;
        bone myoregulation reflex. The aim of this study is to determine the contribution of bone&#xD;
        myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in&#xD;
        postmenopausal and senile osteoporosis (10,11,12,13,14). Osteoporotic cases would be&#xD;
        determined by standard DXA measurements.&#xD;
  &#xD;
        The vibration will be applied with the PowerPlate® Pro5 whole-body vibration (London UK)&#xD;
        device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36&#xD;
        Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be&#xD;
        applied between vibrations of 45 seconds.&#xD;
  &#xD;
        Surface EMG recordings will be taken from the right soleus muscle using the bipolar&#xD;
        technique. A pair of self-adhesive Ag/AgCl (Redline®) electrodes will be adhered to the skin&#xD;
        according to the SENIAM protocol(2). Recordings will be taken in the 1-500 Hz frequency band.&#xD;
        Surface electromyography (EMG) recordings will be taken with a PowerLab ® (ADInstruments,&#xD;
        Oxford, UK) data recorder with a sample rate of 20 KHz. EMG recordings will be analyzed&#xD;
        offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK). The acceleration&#xD;
        measurement data will be recorded with the PowerLab (ADInstrument London) data acquisition&#xD;
        simultaneously with the EMG recording. Acceleration recording will be made with a sample rate&#xD;
        of 20 KHz.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 29, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 8, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bone myoregulation reflex latency</measure>
      <time_frame>up to 2 weeks</time_frame>
      <description>It was defined as the period between the onset of effective mechanical stimulation and the onset of the reflex in surface electromyography.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Sarcopenia</condition>
    <condition>Osteoporosis</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Healthy young-adult groups</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Senile osteoporosis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with senile osteoporosis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Postmenopausal osteoporosis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with postmenopausal osteoporosis</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>whole-body vibration to Control</intervention_name>
      <description>Whole-body vibration (WBV) will be applied while standing upright. During this position, he will be asked not to voluntarily contract the calf muscles and to remain relaxed. The vibration will be applied with the PowerPlate® Pro5 WBV (London UK) device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36 Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be applied between vibrations of 45 seconds.</description>
      <arm_group_label>Control</arm_group_label>
      <arm_group_label>Postmenopausal osteoporosis</arm_group_label>
      <arm_group_label>Senile osteoporosis</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  For healthy young adults control Healthy volunteers aged 20-45 years&#xD;
  &#xD;
            -  For postmenopausal osteoporosis Hip DXA T-score (neck or total hip) &lt; -2.5&#xD;
  &#xD;
            -  For the Senile osteoporosis Over 65 years Male Hip DXA T-score (neck or total hip) &lt;&#xD;
               -2.5 Female&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Osteopenic cases&#xD;
  &#xD;
            -  Possible sarcopenia (according to EWGSOP2 criteria)&#xD;
  &#xD;
            -  Vertigo&#xD;
  &#xD;
            -  Kidney stone&#xD;
  &#xD;
            -  Panic attack story&#xD;
  &#xD;
            -  Secondary osteoporosis&#xD;
  &#xD;
            -  Those with polyneuropathy, central nervous system disease clinic/history&#xD;
  &#xD;
            -  Myopathies (steroid, vitamin D deficiency, primary muscle diseases, etc.)&#xD;
  &#xD;
            -  Cases with lesions on the soleus skin&#xD;
  &#xD;
            -  History of fracture in lower extremity, joint prosthesis&#xD;
  &#xD;
            -  Lower extremity active/acute thrombophlebitis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>TUGBA AYDIN, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>İstanbul Physical Therapy Rehabilitation Training &amp; Research Hosptial</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ILHAN KARACAN, MD</last_name>
      <phone>+905327005361</phone>
      <email>mdkaracanilhan@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>TUGBA AYDIN, MD</last_name>
      <phone>+905324622162</phone>
      <email>drtugbaaydin@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ilhan Karacan</name>
        <address>
          <city>Istanbul</city>
          <state>Kocaeli</state>
          <zip>34303</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>İLHAN KARACAN, MD</last_name>
        <phone>05327005361</phone>
        <email>mdkaracanilhan@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.</citation>
      <PMID>11018445</PMID>
    </reference>
    <reference>
      <citation>Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.</citation>
      <PMID>25100978</PMID>
    </reference>
    <reference>
      <citation>Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.</citation>
      <PMID>31081853</PMID>
    </reference>
    <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>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>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>muscle strength</keyword>
    <keyword>bone mineral density</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Osteoporosis</mesh_term>
      <mesh_term>Sarcopenia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06017245
  org study id: BMROPS
  nct id: NCT06017245
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Bone and skeletal muscle are in a single unit that interacts with each other structurally and
        functionally. The aim of this study is to determine the contribution of bone myoregulation
        reflex as a neuronal crosstalk mechanism on the development of sarcopenia in postmenopausal
        and senile osteoporosis
  Bone and skeletal muscle are in a single unit that interacts with each other structurally and
        functionally. While myokines synthesized and released in skeletal muscle modulate the bone
        formation and destruction process, osteokines synthesized and released by bone cells have
        positive or negative effects on muscle (4,5,6,7,8,9). In addition to humoral crosstalk
        mechanisms between muscle and bone, there is also a neuronal crosstalk mechanism defined as
        bone myoregulation reflex. The aim of this study is to determine the contribution of bone
        myoregulation reflex as a neuronal crosstalk mechanism on the development of sarcopenia in
        postmenopausal and senile osteoporosis (10,11,12,13,14). Osteoporotic cases would be
        determined by standard DXA measurements.
  
        The vibration will be applied with the PowerPlate® Pro5 whole-body vibration (London UK)
        device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36
        Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be
        applied between vibrations of 45 seconds.
  
        Surface EMG recordings will be taken from the right soleus muscle using the bipolar
        technique. A pair of self-adhesive Ag/AgCl (Redline®) electrodes will be adhered to the skin
        according to the SENIAM protocol(2). Recordings will be taken in the 1-500 Hz frequency band.
        Surface electromyography (EMG) recordings will be taken with a PowerLab ® (ADInstruments,
        Oxford, UK) data recorder with a sample rate of 20 KHz. EMG recordings will be analyzed
        offline with LabChart7 Pro® version 7.3.8 (ADInstruments, Oxford, UK). The acceleration
        measurement data will be recorded with the PowerLab (ADInstrument London) data acquisition
        simultaneously with the EMG recording. Acceleration recording will be made with a sample rate
        of 20 KHz.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Bone myoregulation reflex latency
  time frame: up to 2 weeks
  description: It was defined as the period between the onset of effective mechanical stimulation and the onset of the reflex in surface electromyography.
  arm group label: Control
  arm group type: Active Comparator
  description: Healthy young-adult groups
  arm group label: Senile osteoporosis
  arm group type: Experimental
  description: Patients with senile osteoporosis
  arm group label: Postmenopausal osteoporosis
  arm group type: Experimental
  description: Patients with postmenopausal osteoporosis
  intervention type: Device
  intervention name: whole-body vibration to Control
  description: Whole-body vibration (WBV) will be applied while standing upright. During this position, he will be asked not to voluntarily contract the calf muscles and to remain relaxed. The vibration will be applied with the PowerPlate® Pro5 WBV (London UK) device. The vibration amplitude will be 2 mm. The vibration frequency will be 30, 33, and 36 Hz. Each vibration frequency will be applied for 45 seconds. A 5-second rest period will be applied between vibrations of 45 seconds.
  arm group label: Control
  arm group label: Postmenopausal osteoporosis
  arm group label: Senile osteoporosis
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: TUGBA AYDIN, MD
  role: Principal Investigator
  affiliation: İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
  last name: ILHAN KARACAN, MD
  phone: +905327005361
  email: mdkaracanilhan@gmail.com
  last name: TUGBA AYDIN, MD
  phone: +905324622162
  email: drtugbaaydin@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
  PMID: 11018445
  citation: Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
  PMID: 25100978
  citation: Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.
  PMID: 31081853
  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: 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
  responsible party type: Sponsor
  mesh term: Osteoporosis
  mesh term: Sarcopenia