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/NCT05970250</url>
    </required_header>
    <id_info>
      <org_study_id>Eman Mahrous Abdel-Hamed Ahmed</org_study_id>
      <nct_id>NCT05970250</nct_id>
    </id_info>
    <brief_title>Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy</brief_title>
    <official_title>Effect Of Whole Body Vibration Versus Weight Bearing Exercises On Osteoporosis In Breast Cancer Patients After Chemotherapy</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>
        Chemotherapy can damage bone marrow and therefore impair the production of white blood cells,&#xD;
        platelets and red blood cells with the resulting anemia and osteoporosis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Purposes of this study were:&#xD;
  &#xD;
          1. To determine the therapeutic efficacy of the whole-body vibration (WBV) in improving&#xD;
             osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.&#xD;
  &#xD;
          2. To determine the therapeutic efficacy of the weight bearing exercise in improving&#xD;
             osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.&#xD;
  &#xD;
          3. To gain knowledge about the whole-body vibration (WBV) and the weight bearing exercise&#xD;
             in improving osteoporosis in breast cancer patients after receiving chemotherapy within&#xD;
             3-6 months.&#xD;
  &#xD;
          4. To share in designing an ideal protocol for the treatment of the osteoporosis in breast&#xD;
             cancer patients after receiving chemotherapy within 3-6 months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 20, 2022</start_date>
    <completion_date type="Actual">July 20, 2022</completion_date>
    <primary_completion_date type="Actual">April 20, 2022</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Assessing the change in bone mineral density</measure>
      <time_frame>at baseline and after 2 months of intervention</time_frame>
      <description>By using DEXA (dual-energy X-ray absorptiometry): Dual-energy X-ray absorptiometry (DEXA) is a clinically proven method of measuring bone mineral density (BMD) in the lumbar spine, proximal femur, forearm, and whole body. It is used primarily in the diagnosis and management of osteoporosis and other disease states characterized by abnormal BMD, as well as to monitor response to therapy for these conditions .</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">45</enrollment>
    <condition>Osteoporosis</condition>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Whole body vibration group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group (the first study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received the whole body vibration, 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Weight bearing exercises group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group (the second study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received aerobic exercise on treadmill as form of weight bearing exercise 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>drug therapy group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In this group (control group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received only drug therapy (vitamin D supplements and calcium. Measurements were conducted before starting the treatment as a first record, at end of the second month of treatment as second record and make follow up after 3 months as final record.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Whole body vibration group</intervention_name>
      <description>Whole body vibration apparatus (model Power plate -my5tm, made in United States) with frequency 30 - 40 Hz was used for the whole body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.</description>
      <arm_group_label>Whole body vibration group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Weight bearing exercises</intervention_name>
      <description>Electronic treadmill Kettler- marathon model No 7899-800, made in Germany (as form of weight bearing exercises), which was adjusted to the subject's comfortable walking speed. Generally, during the treadmill training, its speed and inclination are electronically adjusted, and it is also provided with a control panel to display the exercise parameters. It allows for the comfortable running without joint or back pains through a perfect combination between aluminium-pertinax running deck, shock absorbers and overall shock-damping design.</description>
      <arm_group_label>Weight bearing exercises group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>vitamin D supplements and calcium</intervention_name>
      <description>vitamin D supplements and calcium</description>
      <arm_group_label>Weight bearing exercises group</arm_group_label>
      <arm_group_label>Whole body vibration group</arm_group_label>
      <arm_group_label>drug therapy group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Breast cancer patients after receiving chemotherapy within 3-6 months and complaining&#xD;
               from osteoporosis.&#xD;
  &#xD;
            -  Their age ranges from 35-55 years old.&#xD;
  &#xD;
            -  All patients will have the same medical and nursing care.&#xD;
  &#xD;
            -  All the patients will receive a good explanation of treatment and measurement device.&#xD;
  &#xD;
            -  They are neurologically free.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients will be excluded from this study for any of the following causes:&#xD;
  &#xD;
            -  Uncooperative patients.&#xD;
  &#xD;
            -  Instability of patient's medical condition.&#xD;
  &#xD;
            -  Association of another medical problem.&#xD;
  &#xD;
            -  Patients who have diabetes.&#xD;
  &#xD;
            -  Patients who have history of medical chronic relevant diseases.&#xD;
  &#xD;
            -  Patients who have acute or chronic hepatitis.&#xD;
  &#xD;
            -  Patients who have pacemaker.&#xD;
  &#xD;
            -  Patients who have genitourinary infections.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eman Elgendy</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Outpatient clinic faculty of physical therapy cairo university</name>
        <address>
          <city>Dokki</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 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>Cairo University</investigator_affiliation>
      <investigator_full_name>Eman Mahrous Abdel-Hamed Ahmed Elgendy</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Osteoporosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin D</mesh_term>
      <mesh_term>Calcium</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05970250
  org study id: Eman Mahrous Abdel-Hamed Ahmed
  nct id: NCT05970250
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Chemotherapy can damage bone marrow and therefore impair the production of white blood cells,
        platelets and red blood cells with the resulting anemia and osteoporosis.
  Purposes of this study were:
  
          1. To determine the therapeutic efficacy of the whole-body vibration (WBV) in improving
             osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
  
          2. To determine the therapeutic efficacy of the weight bearing exercise in improving
             osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.
  
          3. To gain knowledge about the whole-body vibration (WBV) and the weight bearing exercise
             in improving osteoporosis in breast cancer patients after receiving chemotherapy within
             3-6 months.
  
          4. To share in designing an ideal protocol for the treatment of the osteoporosis in breast
             cancer patients after receiving chemotherapy within 3-6 months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Assessing the change in bone mineral density
  time frame: at baseline and after 2 months of intervention
  description: By using DEXA (dual-energy X-ray absorptiometry): Dual-energy X-ray absorptiometry (DEXA) is a clinically proven method of measuring bone mineral density (BMD) in the lumbar spine, proximal femur, forearm, and whole body. It is used primarily in the diagnosis and management of osteoporosis and other disease states characterized by abnormal BMD, as well as to monitor response to therapy for these conditions .
  arm group label: Whole body vibration group
  arm group type: Experimental
  description: In this group (the first study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received the whole body vibration, 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).
  arm group label: Weight bearing exercises group
  arm group type: Experimental
  description: In this group (the second study group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received aerobic exercise on treadmill as form of weight bearing exercise 20 minutes 3 times per week for 2 months and drug therapy (vitamin D supplements and calcium).
  arm group label: drug therapy group
  arm group type: Other
  description: In this group (control group) fifteen breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis were received only drug therapy (vitamin D supplements and calcium. Measurements were conducted before starting the treatment as a first record, at end of the second month of treatment as second record and make follow up after 3 months as final record.
  intervention type: Other
  intervention name: Whole body vibration group
  description: Whole body vibration apparatus (model Power plate -my5tm, made in United States) with frequency 30 - 40 Hz was used for the whole body vibration program by reciprocating vertical displacements on the left and right side of a fulcrum.
  arm group label: Whole body vibration group
  intervention type: Other
  intervention name: Weight bearing exercises
  description: Electronic treadmill Kettler- marathon model No 7899-800, made in Germany (as form of weight bearing exercises), which was adjusted to the subject's comfortable walking speed. Generally, during the treadmill training, its speed and inclination are electronically adjusted, and it is also provided with a control panel to display the exercise parameters. It allows for the comfortable running without joint or back pains through a perfect combination between aluminium-pertinax running deck, shock absorbers and overall shock-damping design.
  arm group label: Weight bearing exercises group
  intervention type: Drug
  intervention name: vitamin D supplements and calcium
  description: vitamin D supplements and calcium
  arm group label: Weight bearing exercises group
  arm group label: Whole body vibration group
  arm group label: drug therapy group
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: 55 Years
  healthy volunteers: No
  last name: Eman Elgendy
  role: Principal Investigator
  affiliation: Cairo University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Eman Mahrous Abdel-Hamed Ahmed Elgendy
  investigator title: Principal Investigator
  mesh term: Breast Neoplasms
  mesh term: Osteoporosis
  mesh term: Vitamin D
  mesh term: Calcium
  sharing ipd: Undecided