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/NCT05982002</url>
    </required_header>
    <id_info>
      <org_study_id>P.T.REC/012/002823</org_study_id>
      <nct_id>NCT05982002</nct_id>
    </id_info>
    <brief_title>Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women</brief_title>
    <official_title>Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women</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>
        This study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (SWT)&#xD;
        on truncal obesity and serum lipids in obese postmenopausal women&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Truncal obesity occurs when the excess abdominal fat around the stomach and abdomen has&#xD;
        accumulated to the point where it is likely to have a negative influence on health ,&#xD;
        increased visceral abdominal fat (VAF) is directly related to abdominal obesity (AO), which&#xD;
        is also linked to endothelial dysfunction, inflammation, insulin resistance, diabetes&#xD;
        mellitus, hypercholesterolemia, hepatic steatosis metabolic syndrome [MetS] and cancer.&#xD;
  &#xD;
        High density lipoprotein (HDL) cholesterol, often known as cardio protective cholesterol,&#xD;
        increases in a hypoestrogenic state such postmenopausal status, whereas triglyceride (TG),&#xD;
        total cholesterol, and LDL cholesterol levels fall The prevention of CVD and dyslipidemia&#xD;
        depends on the management of truncal obesity, and the reduction of serum lipid levels.&#xD;
  &#xD;
        Extracorporeal shock wave therapy (ESWT) has lately been popular for treating fat-related&#xD;
        disorders by altering the permeability of lipocyte membranes, improving blood flow and&#xD;
        hastening macrophages' clearance of debris so cellulite, body contouring and localized fat&#xD;
        can all be treated with the safe and non-invasive ESWT technology because to its mode of&#xD;
        action in biological tissue In order to identify the best methods for treating abdominal&#xD;
        obesity and prevent the risk of developing cardiovascular disease (CVD) in post-menopausal&#xD;
        women. The current randomized controlled trial aimed to determine the effect of&#xD;
        extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese&#xD;
        postmenopausal women.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2020</start_date>
    <completion_date type="Actual">September 1, 2021</completion_date>
    <primary_completion_date type="Actual">December 15, 2020</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>Anrhropometric measurement</measure>
      <time_frame>Before and after 6 weeks of treatment</time_frame>
      <description>involving weight, height, waist circumference and hip circumference measured for each post-menopausal woman . The weight and height were measured using a weight-height scale without shoes and with a thin layer of clothes then calculate the body mass index according to the following equation: BMI=weight/height2 (Kg/m2), for both groups (A&amp;B), waist circumference were measured pare skin from standing position using tape measure at the narrowest level between the costal margin and the iliac crest at the end of gentle expiration, and the hip circumference was measured at the widest level over the buttocks. Then, waist/hip ratio was calculated by dividing the waist by the hip circumference before and after treatment program for all women in both groups (A and B)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lipid profile measurement</measure>
      <time_frame>Before and after 6 weeks of treatment</time_frame>
      <description>Fasting sample of venous blood was collected in the morning from each woman in both groups (A&amp;B) from a vein on the inside of the elbow or the back of the hand after use of local antiseptic for the skin to prevent infection .Serum levels of the total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides (TG) was measured by cobas 311 analyzer using a commercially available assay kit according to the manufacturer's instructions (Roche&#xD;
  Diagnostics GmbH).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Obesity</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Group A: (Control group)20 post menopausal women received moderate intensity aerobic exercise in addition to energy restricted diet 2time/week for 6 -weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Shock wave group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Group B: (shock wave group)20 post menopausal women received the same intervention as in group A and 12 sessions of shockwave on abdomen twice/week for 6 -weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>shock wave</intervention_name>
      <description>ESWT (Chattanooga, Intelect RPW, USA) continues mode, hand piece transmitter R SW D20 /20mm, with the following Parameter: Shock pressure of 3-4 bars, wave frequency of 12 Hz.</description>
      <arm_group_label>Shock wave group</arm_group_label>
      <other_name>Extracorporeal shock wave therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Moderate intensity aerobic exercise</intervention_name>
      <description>Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Shock wave group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Energy-restricted diet</intervention_name>
      <description>energy intake was 500K calorie below daily requirements on average three meals at the same time of the day</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Shock wave group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Obese Post menopausal women Body mass index more than or equal 30kg/m2 Waist&#xD;
               circumference more than or equal 88 cm Waist hip ratio more than or equal 0.88cm Women&#xD;
               not engaged in any procedure to treat obesity or received medication from 6 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  women diagnosed with malignancies or received chemical or radiotherapy or hormone&#xD;
               replacement therapy or corticosteroids or diagnosed with liver disease or active&#xD;
               infection or trauma&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hala Hanafy</last_name>
      <role>Study Director</role>
      <affiliation>Professor of physical therapy for women's health</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Marwa Hasanin</last_name>
      <role>Study Director</role>
      <affiliation>Assistant professor of physical therapy for women's health</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hossam Hussien</last_name>
      <role>Study Director</role>
      <affiliation>Professor of gynaecology and obstetrics</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Faculty of physical therapy</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Troia S, Moreira AM, Pisco D, Noites A, Vale AL, Carvalho P, Vilarinho R. Effect of shock wave therapy associated with aerobic exercise on cellulite: A randomized controlled trial. J Cosmet Dermatol. 2021 Jun;20(6):1732-1742. doi: 10.1111/jocd.13791. Epub 2020 Oct 26.</citation>
      <PMID>33053245</PMID>
    </reference>
    <reference>
      <citation>Zhang X, Ma Y. Global trends in research on extracorporeal shock wave therapy (ESWT) from 2000 to 2021. BMC Musculoskelet Disord. 2023 Apr 20;24(1):312. doi: 10.1186/s12891-023-06407-9.</citation>
      <PMID>37081473</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Hoda mohammed fathey</investigator_full_name>
      <investigator_title>Physiotherapist</investigator_title>
    </responsible_party>
    <keyword>Obesity-menopause-shock wave-lipid profile</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</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/NCT05982002
  org study id: P.T.REC/012/002823
  nct id: NCT05982002
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (SWT)
        on truncal obesity and serum lipids in obese postmenopausal women
  Truncal obesity occurs when the excess abdominal fat around the stomach and abdomen has
        accumulated to the point where it is likely to have a negative influence on health ,
        increased visceral abdominal fat (VAF) is directly related to abdominal obesity (AO), which
        is also linked to endothelial dysfunction, inflammation, insulin resistance, diabetes
        mellitus, hypercholesterolemia, hepatic steatosis metabolic syndrome [MetS] and cancer.
  
        High density lipoprotein (HDL) cholesterol, often known as cardio protective cholesterol,
        increases in a hypoestrogenic state such postmenopausal status, whereas triglyceride (TG),
        total cholesterol, and LDL cholesterol levels fall The prevention of CVD and dyslipidemia
        depends on the management of truncal obesity, and the reduction of serum lipid levels.
  
        Extracorporeal shock wave therapy (ESWT) has lately been popular for treating fat-related
        disorders by altering the permeability of lipocyte membranes, improving blood flow and
        hastening macrophages' clearance of debris so cellulite, body contouring and localized fat
        can all be treated with the safe and non-invasive ESWT technology because to its mode of
        action in biological tissue In order to identify the best methods for treating abdominal
        obesity and prevent the risk of developing cardiovascular disease (CVD) in post-menopausal
        women. The current randomized controlled trial aimed to determine the effect of
        extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese
        postmenopausal women.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Anrhropometric measurement
  time frame: Before and after 6 weeks of treatment
  description: involving weight, height, waist circumference and hip circumference measured for each post-menopausal woman . The weight and height were measured using a weight-height scale without shoes and with a thin layer of clothes then calculate the body mass index according to the following equation: BMI=weight/height2 (Kg/m2), for both groups (A&B), waist circumference were measured pare skin from standing position using tape measure at the narrowest level between the costal margin and the iliac crest at the end of gentle expiration, and the hip circumference was measured at the widest level over the buttocks. Then, waist/hip ratio was calculated by dividing the waist by the hip circumference before and after treatment program for all women in both groups (A and B)
  measure: Lipid profile measurement
  time frame: Before and after 6 weeks of treatment
  description: Fasting sample of venous blood was collected in the morning from each woman in both groups (A&B) from a vein on the inside of the elbow or the back of the hand after use of local antiseptic for the skin to prevent infection .Serum levels of the total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides (TG) was measured by cobas 311 analyzer using a commercially available assay kit according to the manufacturer's instructions (Roche
  Diagnostics GmbH).
  arm group label: Control group
  arm group type: Active Comparator
  description: Group A: (Control group)20 post menopausal women received moderate intensity aerobic exercise in addition to energy restricted diet 2time/week for 6 -weeks
  arm group label: Shock wave group
  arm group type: Experimental
  description: Group B: (shock wave group)20 post menopausal women received the same intervention as in group A and 12 sessions of shockwave on abdomen twice/week for 6 -weeks
  intervention type: Device
  intervention name: shock wave
  description: ESWT (Chattanooga, Intelect RPW, USA) continues mode, hand piece transmitter R SW D20 /20mm, with the following Parameter: Shock pressure of 3-4 bars, wave frequency of 12 Hz.
  arm group label: Shock wave group
  other name: Extracorporeal shock wave therapy
  intervention type: Other
  intervention name: Moderate intensity aerobic exercise
  description: Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week
  arm group label: Control group
  arm group label: Shock wave group
  intervention type: Other
  intervention name: Energy-restricted diet
  description: energy intake was 500K calorie below daily requirements on average three meals at the same time of the day
  arm group label: Control group
  arm group label: Shock wave group
  criteria: 
  gender: Female
  minimum age: 50 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hala Hanafy
  role: Study Director
  affiliation: Professor of physical therapy for women's health
  last name: Marwa Hasanin
  role: Study Director
  affiliation: Assistant professor of physical therapy for women's health
  last name: Hossam Hussien
  role: Study Director
  affiliation: Professor of gynaecology and obstetrics
  facility: 
  country: Egypt
  citation: Troia S, Moreira AM, Pisco D, Noites A, Vale AL, Carvalho P, Vilarinho R. Effect of shock wave therapy associated with aerobic exercise on cellulite: A randomized controlled trial. J Cosmet Dermatol. 2021 Jun;20(6):1732-1742. doi: 10.1111/jocd.13791. Epub 2020 Oct 26.
  PMID: 33053245
  citation: Zhang X, Ma Y. Global trends in research on extracorporeal shock wave therapy (ESWT) from 2000 to 2021. BMC Musculoskelet Disord. 2023 Apr 20;24(1):312. doi: 10.1186/s12891-023-06407-9.
  PMID: 37081473
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Hoda mohammed fathey
  investigator title: Physiotherapist
  mesh term: Obesity
  sharing ipd: No