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Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
shock wave
Moderate intensity aerobic exercise
Energy-restricted diet
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity-menopause-shock wave-lipid profile

Eligibility Criteria

50 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Obese Post menopausal women Body mass index more than or equal 30kg/m2 Waist circumference more than or equal 88 cm Waist hip ratio more than or equal 0.88cm Women not engaged in any procedure to treat obesity or received medication from 6 months Exclusion Criteria: women diagnosed with malignancies or received chemical or radiotherapy or hormone replacement therapy or corticosteroids or diagnosed with liver disease or active infection or trauma

Sites / Locations

  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Shock wave group

Arm 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

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

Outcomes

Primary Outcome Measures

Anrhropometric measurement
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)
Lipid profile measurement
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).

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
August 1, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05982002
Brief Title
Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women
Official Title
Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese postmenopausal women
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity-menopause-shock wave-lipid profile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm 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 Title
Shock wave group
Arm Type
Experimental
Arm 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(s)
shock wave
Other Intervention Name(s)
Extracorporeal shock wave therapy
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Moderate intensity aerobic exercise
Intervention Description
Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week
Intervention Type
Other
Intervention Name(s)
Energy-restricted diet
Intervention Description
energy intake was 500K calorie below daily requirements on average three meals at the same time of the day
Primary Outcome Measure Information:
Title
Anrhropometric measurement
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)
Time Frame
Before and after 6 weeks of treatment
Title
Lipid profile measurement
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).
Time Frame
Before and after 6 weeks of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Obese Post menopausal women Body mass index more than or equal 30kg/m2 Waist circumference more than or equal 88 cm Waist hip ratio more than or equal 0.88cm Women not engaged in any procedure to treat obesity or received medication from 6 months Exclusion Criteria: women diagnosed with malignancies or received chemical or radiotherapy or hormone replacement therapy or corticosteroids or diagnosed with liver disease or active infection or trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Hanafy
Organizational Affiliation
Professor of physical therapy for women's health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marwa Hasanin
Organizational Affiliation
Assistant professor of physical therapy for women's health
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hossam Hussien
Organizational Affiliation
Professor of gynaecology and obstetrics
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33053245
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.
Results Reference
background
PubMed Identifier
37081473
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.
Results Reference
background

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Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women

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