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/NCT05968222</url>
    </required_header>
    <id_info>
      <org_study_id>Universidad de Salamanca</org_study_id>
      <nct_id>NCT05968222</nct_id>
    </id_info>
    <brief_title>Whole Body Vibration and Diabetes Type 2</brief_title>
    <acronym>WBV</acronym>
    <official_title>Whole Body Vibration Exercise Intervention for Glycemic Control in Type 2 Diabetes Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Salamanca</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Salamanca</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>
        Diabetes generates a great impact on society, as well as a concern for health professionals&#xD;
        due to its high and increasing prevalence; there are more and more studies that demonstrate&#xD;
        the effectiveness of vibration platforms and their benefits at a physiological level. The&#xD;
        objective is to analyze the decrease in glycosylated hemoglobin and glycemia levels after the&#xD;
        use of whole body vibration platforms and the possible inclusion of this therapeutic option&#xD;
        within the usual treatments.The sample will be composed of people diagnosed with Type 2&#xD;
        Diabetes Mellitus in the Plasencia area (Cáceres, Extremadura). Participants will be randomly&#xD;
        assigned to the intervention or control group using a randomization list and will follow the&#xD;
        inclusion criteria: healthy type 2 diabetics between 50 and 60 years of age and not taking&#xD;
        diabetes medication. All participants will undergo a determination of glycosylated&#xD;
        hemoglobin, blood pressure, lipid profile, weight and height, and different functional tests&#xD;
        such as TUG, 10MMT, 5STS. The experimental group will perform a full body vibration&#xD;
        intervention on an oscillating platform for 12 weeks with a weekly frequency of 3&#xD;
        non-consecutive days and a duration of 12 minutes. The exercises will consist of 60 seconds&#xD;
        of work and 60 seconds with rest. The control group will carry out their normal life&#xD;
        insisting on the importance of glycemic controls before and after their daily physical&#xD;
        exercise.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 1, 2024</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c.</measure>
      <time_frame>baseline and 12 weeks post</time_frame>
      <description>HbA1c is a blood test to determine the average level of glucose or sugar in the blood during the last two or three months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Timed Up and Go 3 meters (TUG 3 m)</measure>
      <time_frame>baseline and 12 weeks post</time_frame>
      <description>The subject, seated with his back resting on the back of the chair (without armrests and height 43 cm), at the acoustic command following a five-second countdown, stands up, walks the expected distance, turns around a cone, goes back, turns 360° and sits down again. The test time stops when the subject returns to the starting position and is completely immobile.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>10 Meters Walking Test (10 m)</measure>
      <time_frame>baseline and 12 weeks post</time_frame>
      <description>On command the subject covers the distance walking as fast as possible, without running.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Five times Sit To Stand (5STS)</measure>
      <time_frame>baseline and 12 weeks post</time_frame>
      <description>The subject, seated with his back supported on the chair (without armrests and height 43 cm), on command stands up and sits down five consecutive times, as fast as possible and without using the push of the hands on the quadriceps.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control group will undergo a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight and height, as well as functional tests such as TUG, 10MWT, 5STS. Subsequently, they will be encouraged to continue their normal life insisting on the importance of glycemic controls before and after their daily physical exercise. In addition to continuing with the dietary measures recommended by their specialist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the intervention group will be subjected to the following tests:&#xD;
  At the beginning of the intervention, a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight, height and TUG, 10MWT, 5STS, which will be repeated after 12 weeks of intervention.&#xD;
  Before each training session, participants will undergo a basal blood glucose and blood pressure measurement, which will be repeated after the end of the session.&#xD;
  Each training session on the vibrating platform is composed of 6 exercises with a duration of 60 seconds with 60-second pauses between exercises and a warm-up exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Vibration exercise</intervention_name>
      <description>Each training session on the vibrating platform is composed of 6 exercises with a duration of 60 seconds with 60-second pauses between exercises and a warm-up exercise</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Not taking medication for diabetes.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Suffer a pathology (such as diabetic retinopathy, diabetic nephropathy), mobility&#xD;
               disability and/or comorbidities incompatible with physical exercise and the use of&#xD;
               vibration platforms, previous hip or knee surgeries, cognitive impairment and&#xD;
               neurological pathology&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Vicente Rodríguez Pérez, PhD.</last_name>
      <phone>0034923244590</phone>
      <phone_ext>3162</phone_ext>
      <email>vicente.rodriguez@usal.es</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Salamanca</name>
        <address>
          <city>Salamanca</city>
          <zip>37007</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Vicente Rodríguez Pérez, PhD</last_name>
        <phone>0034923294590</phone>
        <phone_ext>3162</phone_ext>
        <email>vicente.rodriguez@usal.es</email>
      </contact>
      <investigator>
        <last_name>Rocío Llamas Ramos, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Inés Llamas Ramos, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <reference>
      <citation>Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.</citation>
      <PMID>12562163</PMID>
    </reference>
    <reference>
      <citation>Rodriguez-Reyes RR, Navarro-Zarza JE, Tello-Divicino TL, Parra-Rojas I, Zaragoza-Garcia O, Guzman-Guzman IP. [Detection of cardiovascular risk in healthcare workers on the basis of WHO/JNC 7/ATP III criteria]. Rev Med Inst Mex Seguro Soc. 2017 May-Jun;55(3):300-308. Spanish.</citation>
      <PMID>28440983</PMID>
    </reference>
    <reference>
      <citation>del Pozo-Cruz B, Alfonso-Rosa RM, del Pozo-Cruz J, Sanudo B, Rogers ME. Effects of a 12-wk whole-body vibration based intervention to improve type 2 diabetes. Maturitas. 2014 Jan;77(1):52-8. doi: 10.1016/j.maturitas.2013.09.005. Epub 2013 Sep 18.</citation>
      <PMID>24094494</PMID>
    </reference>
    <reference>
      <citation>Bonaiuti D, Shea B, Iovine R, Negrini S, Robinson V, Kemper HC, Wells G, Tugwell P, Cranney A. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2002;(3):CD000333. doi: 10.1002/14651858.CD000333.</citation>
      <PMID>12137611</PMID>
    </reference>
    <reference>
      <citation>Behboudi L, Azarbayjani MA, Aghaalinejad H, Salavati M. Effects of aerobic exercise and whole body vibration on glycaemia control in type 2 diabetic males. Asian J Sports Med. 2011 Jun;2(2):83-90. doi: 10.5812/asjsm.34789.</citation>
      <PMID>22375223</PMID>
    </reference>
    <reference>
      <citation>Gusi N, Parraca JA, Olivares PR, Leal A, Adsuar JC. Tilt vibratory exercise and the dynamic balance in fibromyalgia: A randomized controlled trial. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1072-8. doi: 10.1002/acr.20180.</citation>
      <PMID>20235191</PMID>
    </reference>
    <reference>
      <citation>Sanudo B, de Hoyo M, Carrasco L, McVeigh JG, Corral J, Cabeza R, Rodriguez C, Oliva A. The effect of 6-week exercise programme and whole body vibration on strength and quality of life in women with fibromyalgia: a randomised study. Clin Exp Rheumatol. 2010 Nov-Dec;28(6 Suppl 63):S40-5. Epub 2010 Dec 22.</citation>
      <PMID>21122265</PMID>
    </reference>
    <reference>
      <citation>Marazzi S, Kiper P, Palmer K, Agostini M, Turolla A. Effects of vibratory stimulation on balance and gait in Parkinson's disease: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2021 Apr;57(2):254-264. doi: 10.23736/S1973-9087.20.06099-2. Epub 2020 Jan 14.</citation>
      <PMID>31939269</PMID>
    </reference>
    <reference>
      <citation>Kang H, Lu J, Xu G. The effects of whole body vibration on muscle strength and functional mobility in persons with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2016 May;7:1-7. doi: 10.1016/j.msard.2016.02.008. Epub 2016 Feb 8.</citation>
      <PMID>27237747</PMID>
    </reference>
    <reference>
      <citation>Slatkovska L, Alibhai SM, Beyene J, Hu H, Demaras A, Cheung AM. Effect of 12 months of whole-body vibration therapy on bone density and structure in postmenopausal women: a randomized trial. Ann Intern Med. 2011 Nov 15;155(10):668-79, W205. doi: 10.7326/0003-4819-155-10-201111150-00005. Erratum In: Ann Intern Med. 2011 Dec 20;155(12):860.</citation>
      <PMID>22084333</PMID>
    </reference>
    <reference>
      <citation>Tseng CL, Brimacombe M, Xie M, Rajan M, Wang H, Kolassa J, Crystal S, Chen TC, Pogach L, Safford M. Seasonal patterns in monthly hemoglobin A1c values. Am J Epidemiol. 2005 Mar 15;161(6):565-74. doi: 10.1093/aje/kwi071.</citation>
      <PMID>15746473</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Salamanca</investigator_affiliation>
      <investigator_full_name>Vicente Rodríguez Pérez</investigator_full_name>
      <investigator_title>Ph.D.</investigator_title>
    </responsible_party>
    <keyword>Whole Body Vibration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</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/NCT05968222
  org study id: Universidad de Salamanca
  nct id: NCT05968222
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Diabetes generates a great impact on society, as well as a concern for health professionals
        due to its high and increasing prevalence; there are more and more studies that demonstrate
        the effectiveness of vibration platforms and their benefits at a physiological level. The
        objective is to analyze the decrease in glycosylated hemoglobin and glycemia levels after the
        use of whole body vibration platforms and the possible inclusion of this therapeutic option
        within the usual treatments.The sample will be composed of people diagnosed with Type 2
        Diabetes Mellitus in the Plasencia area (Cáceres, Extremadura). Participants will be randomly
        assigned to the intervention or control group using a randomization list and will follow the
        inclusion criteria: healthy type 2 diabetics between 50 and 60 years of age and not taking
        diabetes medication. All participants will undergo a determination of glycosylated
        hemoglobin, blood pressure, lipid profile, weight and height, and different functional tests
        such as TUG, 10MMT, 5STS. The experimental group will perform a full body vibration
        intervention on an oscillating platform for 12 weeks with a weekly frequency of 3
        non-consecutive days and a duration of 12 minutes. The exercises will consist of 60 seconds
        of work and 60 seconds with rest. The control group will carry out their normal life
        insisting on the importance of glycemic controls before and after their daily physical
        exercise.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Investigator)
  measure: HbA1c.
  time frame: baseline and 12 weeks post
  description: HbA1c is a blood test to determine the average level of glucose or sugar in the blood during the last two or three months
  measure: Timed Up and Go 3 meters (TUG 3 m)
  time frame: baseline and 12 weeks post
  description: The subject, seated with his back resting on the back of the chair (without armrests and height 43 cm), at the acoustic command following a five-second countdown, stands up, walks the expected distance, turns around a cone, goes back, turns 360° and sits down again. The test time stops when the subject returns to the starting position and is completely immobile.
  measure: 10 Meters Walking Test (10 m)
  time frame: baseline and 12 weeks post
  description: On command the subject covers the distance walking as fast as possible, without running.
  measure: Five times Sit To Stand (5STS)
  time frame: baseline and 12 weeks post
  description: The subject, seated with his back supported on the chair (without armrests and height 43 cm), on command stands up and sits down five consecutive times, as fast as possible and without using the push of the hands on the quadriceps.
  arm group label: Control group
  arm group type: No Intervention
  description: Participants in the control group will undergo a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight and height, as well as functional tests such as TUG, 10MWT, 5STS. Subsequently, they will be encouraged to continue their normal life insisting on the importance of glycemic controls before and after their daily physical exercise. In addition to continuing with the dietary measures recommended by their specialist.
  arm group label: Experimental group
  arm group type: Experimental
  description: Participants in the intervention group will be subjected to the following tests:
  At the beginning of the intervention, a determination of glycosylated hemoglobin, blood pressure, lipid profile, weight, height and TUG, 10MWT, 5STS, which will be repeated after 12 weeks of intervention.
  Before each training session, participants will undergo a basal blood glucose and blood pressure measurement, which will be repeated after the end of the session.
  Each training session on the vibrating platform is composed of 6 exercises with a duration of 60 seconds with 60-second pauses between exercises and a warm-up exercise.
  intervention type: Other
  intervention name: Vibration exercise
  description: Each training session on the vibrating platform is composed of 6 exercises with a duration of 60 seconds with 60-second pauses between exercises and a warm-up exercise
  arm group label: Experimental group
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Vicente Rodríguez Pérez, PhD.
  phone: 0034923244590
  phone ext: 3162
  email: vicente.rodriguez@usal.es
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Spain
  citation: Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc Sport Sci Rev. 2003 Jan;31(1):3-7. doi: 10.1097/00003677-200301000-00002.
  PMID: 12562163
  citation: Rodriguez-Reyes RR, Navarro-Zarza JE, Tello-Divicino TL, Parra-Rojas I, Zaragoza-Garcia O, Guzman-Guzman IP. [Detection of cardiovascular risk in healthcare workers on the basis of WHO/JNC 7/ATP III criteria]. Rev Med Inst Mex Seguro Soc. 2017 May-Jun;55(3):300-308. Spanish.
  PMID: 28440983
  citation: del Pozo-Cruz B, Alfonso-Rosa RM, del Pozo-Cruz J, Sanudo B, Rogers ME. Effects of a 12-wk whole-body vibration based intervention to improve type 2 diabetes. Maturitas. 2014 Jan;77(1):52-8. doi: 10.1016/j.maturitas.2013.09.005. Epub 2013 Sep 18.
  PMID: 24094494
  citation: Bonaiuti D, Shea B, Iovine R, Negrini S, Robinson V, Kemper HC, Wells G, Tugwell P, Cranney A. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2002;(3):CD000333. doi: 10.1002/14651858.CD000333.
  PMID: 12137611
  citation: Behboudi L, Azarbayjani MA, Aghaalinejad H, Salavati M. Effects of aerobic exercise and whole body vibration on glycaemia control in type 2 diabetic males. Asian J Sports Med. 2011 Jun;2(2):83-90. doi: 10.5812/asjsm.34789.
  PMID: 22375223
  citation: Gusi N, Parraca JA, Olivares PR, Leal A, Adsuar JC. Tilt vibratory exercise and the dynamic balance in fibromyalgia: A randomized controlled trial. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1072-8. doi: 10.1002/acr.20180.
  PMID: 20235191
  citation: Sanudo B, de Hoyo M, Carrasco L, McVeigh JG, Corral J, Cabeza R, Rodriguez C, Oliva A. The effect of 6-week exercise programme and whole body vibration on strength and quality of life in women with fibromyalgia: a randomised study. Clin Exp Rheumatol. 2010 Nov-Dec;28(6 Suppl 63):S40-5. Epub 2010 Dec 22.
  PMID: 21122265
  citation: Marazzi S, Kiper P, Palmer K, Agostini M, Turolla A. Effects of vibratory stimulation on balance and gait in Parkinson's disease: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2021 Apr;57(2):254-264. doi: 10.23736/S1973-9087.20.06099-2. Epub 2020 Jan 14.
  PMID: 31939269
  citation: Kang H, Lu J, Xu G. The effects of whole body vibration on muscle strength and functional mobility in persons with multiple sclerosis: A systematic review and meta-analysis. Mult Scler Relat Disord. 2016 May;7:1-7. doi: 10.1016/j.msard.2016.02.008. Epub 2016 Feb 8.
  PMID: 27237747
  citation: Slatkovska L, Alibhai SM, Beyene J, Hu H, Demaras A, Cheung AM. Effect of 12 months of whole-body vibration therapy on bone density and structure in postmenopausal women: a randomized trial. Ann Intern Med. 2011 Nov 15;155(10):668-79, W205. doi: 10.7326/0003-4819-155-10-201111150-00005. Erratum In: Ann Intern Med. 2011 Dec 20;155(12):860.
  PMID: 22084333
  citation: Tseng CL, Brimacombe M, Xie M, Rajan M, Wang H, Kolassa J, Crystal S, Chen TC, Pogach L, Safford M. Seasonal patterns in monthly hemoglobin A1c values. Am J Epidemiol. 2005 Mar 15;161(6):565-74. doi: 10.1093/aje/kwi071.
  PMID: 15746473
  responsible party type: Principal Investigator
  investigator affiliation: University of Salamanca
  investigator full name: Vicente Rodríguez Pérez
  investigator title: Ph.D.
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2