Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat

Study Overview
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Brief Summary
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Overweight and obesity is prevalent among women of reproductive age (25-34 years) with 42% having a BMI > 25 kg/m2. Weight gain increases the risk of developing diabetes and cardiovascular disease. The amount of weight regain postpartum can shift women from the healthy weight category into the overweight or obese BMI categories. Purpose: This study was conducted to compare the effectiveness of ultra-sound Cavitation versus radiofrequency on abdominal fat thickness on postnatal women

Detailed Description
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Fifty overweight primipara women at 6 months postnatally aged from 20-35 years, BMI (25-29.9) kg/m2 and have waist hip ratio (WHR) > 0.8. They were assigned randomly into 2 equal groups: Group (A) received ultra-sound cavitation40 KHz applied for 30 min, once time weekly for 8 weeks. Group (B) received radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks. Both groups received the same diet program throughout the treatment period. All females in both groups were assessed through weight scale for body weight, tape measurement for waist/hip ratio and ultra-sonography for fat thickness of abdominal region before and after treatment

Official Title
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Effect of Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat Thickness in Postnatal Women

Conditions
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Healthy Diet

Intervention / Treatment
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* Other: healthy diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Their age were ranged from 20 to 35 years their body mass index BMI 25-29.9 kg/m2 their waist hip ratio (WHR) > 0.8. Exclusion Criteria: heart disease high cholesterol liver kidney diseases

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years


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
Interventional Model Description: Fifty overweight primipara women at 6 months postnatally aged from 20-35 years, BMI (25-29.9) kg/m2 and have waist hip ratio (WHR) > 0.8. They were assigned randomly into 2 equal groups: Group (A) received ultra-sound cavitation40 KHz applied for 30 min, once time weekly for 8 weeks. Group (B) received radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks. Both groups received the same diet program throughout the treatment period. All females in both groups were assessed through weight scale for body weight, tape measurement for waist/hip ratio and ultra-sonography for fat thickness of abdominal region before and after treatment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ultra-sound cavitation<br>cavitation40 KHz applied for 30 min, once time weekly for 8 weeks. | Other: healthy diet<br>* balanced diet program which ranged from 1600 kcal to 2000 kcal/day, which was calculated in an individual basis for each woman according to her basal metabolic rate (BMR) for 8 weeks<br>|
| Experimental: radiofrequency<br>radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks | Other: healthy diet<br>* balanced diet program which ranged from 1600 kcal to 2000 kcal/day, which was calculated in an individual basis for each woman according to her basal metabolic rate (BMR) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI calculation | The woman's BMI had calculated from measured weight & height for each woman in both groups (A&B) before beginning of the study and weight only had measured after 8 weeks of treatment sessions to according to the following equation: BMI=weight (Kg) /height (m2) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist to hip ratio Measurement | WHR was calculated by dividing WC on HC. Both measurements were taken for all women in all groups (A & B) before starting the study and after 8 weeks of treatment sessions (end of study). All measurements were with the women in standing position. Skin of the anterior abdominal wall was cleaned while the woman in hip circumference worn light clothes and sometimes measurements repeated twice for more accurate. That measured WC, HC to measure (WHR) calculated by dividing the measurement of the waist by the measurement of the hips. WHR= (waist circumference / hip circumference) | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultra-sound cavitation, Radiofrequency, fat thickness