<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/NCT04488328</url>
  </required_header>
  <id_info>
    <org_study_id>68m</org_study_id>
    <nct_id>NCT04488328</nct_id>
  </id_info>
  <brief_title>Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis</brief_title>
  <official_title>Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Objectives; This study was conducted to investigate the effect of pulsed magnetic therapy and&#xD;
      aerobic exercise on post thyroidectomy osteoporosis.&#xD;
&#xD;
      Methods; Forty-five female patients, age ranged from 40 to 50 years old with osteoporotic&#xD;
      changes in hip and pelvic region post thyroidectomy, were included in this study. They were&#xD;
      selected from Endocrinology private clinics. They were assigned randomly into three groups,&#xD;
      equal in number. Magnetic Therapy Group (group A); patients received the routine medical&#xD;
      treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on&#xD;
      the pelvic region for 12 weeks (3 sessions/ week). Exercise group(group B); patients received&#xD;
      the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks&#xD;
      (3 sessions/week). Combined Magnetic Therapy and Exercise Therapy group (group C): patients&#xD;
      received the routine medical treatment in addition to pulsed magnetic therapy and&#xD;
      moderate-intensity aerobic exercise for 12 weeks. Evaluation of the three groups was&#xD;
      performed at baseline and after 12 weeks of treatment by dual energy x-ray absorptiometry&#xD;
      (DEXA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 10, 2018</start_date>
  <completion_date type="Actual">September 20, 2019</completion_date>
  <primary_completion_date type="Actual">May 5, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Osteoporosis changes</measure>
    <time_frame>12 weeks</time_frame>
    <description>BMD by DEXA on each group</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Osteoporosis</condition>
  <arm_group>
    <arm_group_label>Magnetic Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined Magnetic Therapy and Exercise Therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks</intervention_name>
    <description>patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks(3 sessions/ week)</description>
    <arm_group_label>Combined Magnetic Therapy and Exercise Therapy group</arm_group_label>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_label>Magnetic Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants had undergone thyroidectomy since 6 months and had cognitive and&#xD;
             educational level enough to understand the requirements of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All Patients with malignancies or receiving radiotherapy or chemotherapy, skin&#xD;
             diseases, deep venous thrombosis or venous insufficiency, sensory impairment, renal&#xD;
             failure, recent therapy with immunosuppressant or anticonvulsants, psychological&#xD;
             problems or alcoholic drinkers were excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marwa Eid</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marwa Eid</name>
      <address>
        <city>Cairo</city>
        <zip>2011</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marwa Eid</investigator_full_name>
    <investigator_title>assistant professor of physical therapy for surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04488328
org study id: 68m
nct id: NCT04488328
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Objectives; This study was conducted to investigate the effect of pulsed magnetic therapy and
      aerobic exercise on post thyroidectomy osteoporosis.

      Methods; Forty-five female patients, age ranged from 40 to 50 years old with osteoporotic
      changes in hip and pelvic region post thyroidectomy, were included in this study. They were
      selected from Endocrinology private clinics. They were assigned randomly into three groups,
      equal in number. Magnetic Therapy Group (group A); patients received the routine medical
      treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on
      the pelvic region for 12 weeks (3 sessions/ week). Exercise group(group B); patients received
      the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks
      (3 sessions/week). Combined Magnetic Therapy and Exercise Therapy group (group C): patients
      received the routine medical treatment in addition to pulsed magnetic therapy and
      moderate-intensity aerobic exercise for 12 weeks. Evaluation of the three groups was
      performed at baseline and after 12 weeks of treatment by dual energy x-ray absorptiometry
      (DEXA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Osteoporosis changes
time frame: 12 weeks
description: BMD by DEXA on each group
arm group label: Magnetic Therapy Group
arm group type: Experimental
description: patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks
arm group label: Exercise group
arm group type: Experimental
description: patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks
arm group label: Combined Magnetic Therapy and Exercise Therapy group
arm group type: Experimental
description: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks
intervention type: Other
intervention name: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks
description: patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks(3 sessions/ week)
arm group label: Combined Magnetic Therapy and Exercise Therapy group
arm group label: Exercise group
arm group label: Magnetic Therapy Group
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 50 Years
healthy volunteers: No
last name: Marwa Eid
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marwa Eid
investigator title: assistant professor of physical therapy for surgery
mesh term: Osteoporosis
sharing ipd: Undecided