Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat

NCT04452552 | Completed DMC

• 1 other identifier: 98
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Diet

Keywords

Ultra-sound cavitation; Radiofrequency; fat thickness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Waist to hip ratio Measurement

  8 weeks

Study Arms (2)

ultra-sound cavitation

EXPERIMENTAL

cavitation40 KHz applied for 30 min, once time weekly for 8 weeks.

Other: healthy diet

radiofrequency

EXPERIMENTAL

radiofrequency multi-polar 5MHZ applied for 30 min, once time weekly for 8 weeks

Other: healthy diet

Interventions

healthy diet OTHER

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

radiofrequency; ultra-sound cavitation

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• heart disease
• high cholesterol
• liver
• kidney diseases

Sponsors & Collaborators

• Cairo University: lead
• Yasmin Mohamed Assim: collaborator

Study Sites (1)

Ghada Elrefaye

Giza, Cairo Governorate, 02, Egypt

Location

MeSH Terms

Interventions

Diet, Healthy

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• ghada eb elrefaye, professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: An independent person randomly assigned to all participated subjects to either group (A) or group (B)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Model Details: 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

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: January 24, 2010
• Primary Completion: May 30, 2020
• Study Completion: June 1, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

EG (1)