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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: shock wave
* Other: Moderate intensity aerobic exercise
* Other: Energy-restricted diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Group A: (Control group)20 post menopausal women received moderate intensity aerobic exercise in addition to energy restricted diet 2time/week for 6 -weeks | Other: Moderate intensity aerobic exercise<br>* Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week<br>Other: Energy-restricted diet<br>* energy intake was 500K calorie below daily requirements on average three meals at the same time of the day<br>|
| Experimental: Shock wave group<br>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 | Device: shock wave<br>* 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.<br>* Other names: Extracorporeal shock wave therapy;Other: Moderate intensity aerobic exercise<br>* Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week<br>Other: Energy-restricted diet<br>* energy intake was 500K calorie below daily requirements on average three meals at the same time of the day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Before and after 6 weeks of treatment | 
| 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). | Before and after 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity-menopause-shock wave-lipid profile