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/NCT05991050</url>
    </required_header>
    <id_info>
      <org_study_id>70</org_study_id>
      <nct_id>NCT05991050</nct_id>
    </id_info>
    <brief_title>Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women.</brief_title>
    <official_title>Effect of Whole Body Vibration on Blood Pressure in Obese Postmenopausal Women. A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that&#xD;
        creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average&#xD;
        daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary&#xD;
        Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat,&#xD;
        sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole&#xD;
        grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as&#xD;
        vitamins A, C and E.Group B (WBV group):&#xD;
  &#xD;
        For 8 weeks, WBV participants completed 3 supervised training sessions a week.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        I-Group A (control group):&#xD;
  &#xD;
        All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that&#xD;
        creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average&#xD;
        daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary&#xD;
        Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat,&#xD;
        sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole&#xD;
        grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as&#xD;
        vitamins A, C and E.&#xD;
  &#xD;
        II-Group B (WBV group):&#xD;
  &#xD;
        For 8 weeks, WBV participants completed 3 supervised training sessions a week. Each&#xD;
        participant received an explanation of the WBV device and the treatment protocol. Women stood&#xD;
        in upright position and hold on handle bar before switching the WBV device at &quot;on&quot; position.&#xD;
  &#xD;
        The exercises were consisted of dynamic squats starting from upright position into the&#xD;
        assigned degree of knee ﬂexion &quot;squats with 90° knee angle, semi-squats with 120° knee angle&quot;&#xD;
        and heel elevation (calf-raise), each exercise was performed for 3 sets and each set&#xD;
        consisted of 5 repetitions. All dynamic exercises were performed with slow controlled&#xD;
        movements and between each set, there was resting period during which women assumed upright&#xD;
        standing position for 1 minute. Total duration of the training session was 30 minutes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">February 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure measurement</measure>
      <time_frame>before and after 8 weeks of treatment</time_frame>
      <description>The auscultatory method of measuring both systolic and diastolic blood pressure was used with a sphygmomanometer properly calibrated and validated</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anthropometric measurements</measure>
      <time_frame>before and after 8 weeks of treatment</time_frame>
      <description>using standardized equipment (Weight and height scale). Height of all participants were measured in standing position without footwear. Body mass index was then calculated</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Diet regimen group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>whole body vibration group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>For 8 weeks, WBV participants completed 3 supervised training sessions a week. The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee ﬂexion &quot;squats with 90° knee angle, semi-squats with 120° knee angle&quot; and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>energy-restricted diet</intervention_name>
      <description>Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.</description>
      <arm_group_label>Diet regimen group</arm_group_label>
      <arm_group_label>whole body vibration group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Whole body vibration</intervention_name>
      <description>For 8 weeks, WBV participants completed 3 supervised training sessions a week. The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee ﬂexion &quot;squats with 90° knee angle, semi-squats with 120° knee angle&quot; and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions.</description>
      <arm_group_label>whole body vibration group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 55 -65 years&#xD;
  &#xD;
            -  BMI 30 to 34.99 Kg / m2&#xD;
  &#xD;
            -  prehypertension and hypertension stage I&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  systolic blood pressure exceeding 159 mm Hg and diastolic blood pressure exceeding 99&#xD;
               mm Hg,&#xD;
  &#xD;
            -  diabetic neuropathy disease,&#xD;
  &#xD;
            -  patients with mental or psychological disorders,&#xD;
  &#xD;
            -  skin disorders or bleeding disorders, and&#xD;
  &#xD;
            -  musculoskeletal disorders that limited WBV.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ahmed M Maged</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ahmed M Maged</last_name>
      <phone>+201005227404</phone>
      <email>Ahmedmaged@cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wafaa Kamal</last_name>
      <phone>01006914119</phone>
      <email>wafaa_kamal37@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kasr Alainy medical school</name>
        <address>
          <city>Cairo</city>
          <zip>12111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Ahmed M Maged, MD</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
    </condition_browse>
    <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/NCT05991050
  org study id: 70
  nct id: NCT05991050
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that
        creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average
        daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary
        Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat,
        sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole
        grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as
        vitamins A, C and E.Group B (WBV group):
  
        For 8 weeks, WBV participants completed 3 supervised training sessions a week.
  I-Group A (control group):
  
        All post-menopausal women followed an energy-restricted diet for 8 weeks. Meal plan that
        creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average
        daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary
        Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat,
        sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole
        grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as
        vitamins A, C and E.
  
        II-Group B (WBV group):
  
        For 8 weeks, WBV participants completed 3 supervised training sessions a week. Each
        participant received an explanation of the WBV device and the treatment protocol. Women stood
        in upright position and hold on handle bar before switching the WBV device at "on" position.
  
        The exercises were consisted of dynamic squats starting from upright position into the
        assigned degree of knee ﬂexion "squats with 90° knee angle, semi-squats with 120° knee angle"
        and heel elevation (calf-raise), each exercise was performed for 3 sets and each set
        consisted of 5 repetitions. All dynamic exercises were performed with slow controlled
        movements and between each set, there was resting period during which women assumed upright
        standing position for 1 minute. Total duration of the training session was 30 minutes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Blood pressure measurement
  time frame: before and after 8 weeks of treatment
  description: The auscultatory method of measuring both systolic and diastolic blood pressure was used with a sphygmomanometer properly calibrated and validated
  measure: Anthropometric measurements
  time frame: before and after 8 weeks of treatment
  description: using standardized equipment (Weight and height scale). Height of all participants were measured in standing position without footwear. Body mass index was then calculated
  arm group label: Diet regimen group
  arm group type: Active Comparator
  description: an energy-restricted diet for 8 weeks. Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.
  arm group label: whole body vibration group
  arm group type: Active Comparator
  description: For 8 weeks, WBV participants completed 3 supervised training sessions a week. The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee ﬂexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions.
  intervention type: Dietary Supplement
  intervention name: energy-restricted diet
  description: Meal plan that creates an energy deficit of 500 to 1000 Kcal per day less than the individual's average daily intake was suitable for weight reduction.Each post-menopausal woman followed Dietary Approaches to Stop Hypertension (DASH) which : low in total fat, cholesterol, red meat, sweets and sugar containing beverages, emphasize fish, nuts, fruits, vegetables and whole grains and it also rich in Potassium(6900mg), Calcium(1200-1500mg) and Magnesium, as well as vitamins A, C and E.
  arm group label: Diet regimen group
  arm group label: whole body vibration group
  intervention type: Device
  intervention name: Whole body vibration
  description: For 8 weeks, WBV participants completed 3 supervised training sessions a week. The exercises were consisted of dynamic squats starting from upright position into the assigned degree of knee ﬂexion "squats with 90° knee angle, semi-squats with 120° knee angle" and heel elevation (calf-raise), each exercise was performed for 3 sets and each set consisted of 5 repetitions.
  arm group label: whole body vibration group
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 55 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Ahmed M Maged
  role: Principal Investigator
  affiliation: Cairo University
  last name: Ahmed M Maged
  phone: +201005227404
  email: Ahmedmaged@cu.edu.eg
  last name: Wafaa Kamal
  phone: 01006914119
  email: wafaa_kamal37@yahoo.com
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Ahmed M Maged, MD
  investigator title: professor
  mesh term: Hypertension
  sharing ipd: No