Ultrasound Cavitation Versus Radiofrequency on Abdominal Fat

NCT ID: NCT04452552

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-24
• Study Completion Date: 2020-06-01

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

Detailed 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

Conditions

Healthy Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ultra-sound cavitation

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

Group Type: EXPERIMENTAL

healthy diet

Intervention Type: 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

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

Group Type: EXPERIMENTAL

healthy diet

Intervention Type: 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

Interventions

healthy diet

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Accepts Healthy Volunteers: Yes

Sponsors

Yasmin Mohamed Assim

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Ebrahim El Refaye

assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ghada eb elrefaye, professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Ghada Elrefaye

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

98

Identifier Type: -

Identifier Source: org_study_id