Effect of Ultrasound Cavitation Versus Whole Body Vibration on Abdominal Fat in Obese Adolescent Females

NCT ID: NCT06529211

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2024-12-10

Brief Summary

This study aims to determine the differences between the effect of ultrasound cavitation and whole-body vibration on abdominal fat in obese adolescent females

Detailed Description

Adolescence is a critical time associated with the development of obesity. About 80% of adolescents with obesity will continue to have this condition as an adult.

Obesity during adolescence is associated with a number of short- and long-term diseases including hypertension, diabetes mellitus type 2, hyperlipidemia, obstructive sleep apnea, psychological distress and future cardiovascular complications.

The investigators showed that there is an increasing demand for non-surgical procedures in the management of obesity that led to the development of non-invasive techniques for reducing localized subcutaneous adipose tissue.

One of these techniques is focused ultrasound cavitation. Research studies showed some benefits in the treatment of excess abdominal fat deposits with reduction in fat circumference without significant side effects.

Also, another non-invasive technique is whole body vibration (WBV). Some studies showed that when it is combined with dietary intervention leads to body weight reduction and improvement of overall body composition and fat reduction including abdominal fat

Both ultrasound cavitation (UC) and whole-body vibration (WBV) are non-invasive modalities with many positive effects on abdominal fat in obese adolescent females. The effect of both the UC and WBV has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of abdominal fat in obese adolescent females. Therefore, this study will be conducted to explore the effect of UC versus WBV on abdominal fat in obese adolescent females.

Conditions

Abdominal Obesity

Study Design

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

Study Groups

Low caloric diet group

low-caloric diet of 1500 kcal/day.

Group Type: ACTIVE_COMPARATOR

Low caloric diet

Intervention Type: DIETARY_SUPPLEMENT

Low caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake.

ultrasound cavitation group

The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1500 kcal/day.

Group Type: EXPERIMENTAL

Low caloric diet

Intervention Type: DIETARY_SUPPLEMENT

Low caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake.

Ultrasound cavitation

Intervention Type: DEVICE

Ultrasound cavitation + Low caloric diet Low caloric diet program (1500 Kcal/ day): for 6 weeks.

Ultrasound cavitation: It will be on abdomen for 30 minutes/session, 2 sessions/week for 6 weeks as follows:

• The participants will be in supine lying position and the abdomen is divided into two sides right and left from the midline.
• The Ultrasound pulsed waves will be set with power input (AC100/ 240V), frequency (40 KHz), and Power output (45W). This will be for 15 minutes on each abdominal side.

whole-body vibration group

The participants will be treated by whole body vibration, in addition to the low-caloric diet of 1500 kcal/day.

Group Type: EXPERIMENTAL

Low caloric diet

Intervention Type: DIETARY_SUPPLEMENT

Low caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake.

Whole body vibration

Intervention Type: DEVICE

Whole body vibration + Low caloric diet Low caloric diet program (1500 Kcal/ day) for 6 weeks.

Whole body vibration: for 30 minutes/session, 2 sessions/week for 6 weeks as follows:

• The participants will begin with a brief warm-up for 5 minutes by doing deep breathing exercises.
• Then they will stand with feet shoulder-width apart on the platform while holding handrails to maintain balance and stability. They will be instructed to relax and allow the vibrations to pass through her body. This will be applied for 20 minutes per session.
• The vibration will be started with lower settings and gradually will be increased till the desired frequency and amplitude (45 HZ) will be reached.
• After the session will be completed, the participant will be instructed to cool down gradually by doing deep breathing for 5 minutes to help their body to return to a resting state. They will be advised to drink plenty of water to be hydrated and recovered after the WBV session.

Interventions

Low caloric diet

Low caloric diet: the participants will receive low caloric diet program (1500 Kcal/ day) for 6 weeks as follows: 45% carbohydrate, 20% fat and 35% proteins of total calorie intake.

Intervention Type: DIETARY_SUPPLEMENT

Ultrasound cavitation

Ultrasound cavitation + Low caloric diet Low caloric diet program (1500 Kcal/ day): for 6 weeks.

Ultrasound cavitation: It will be on abdomen for 30 minutes/session, 2 sessions/week for 6 weeks as follows:

• The participants will be in supine lying position and the abdomen is divided into two sides right and left from the midline.
• The Ultrasound pulsed waves will be set with power input (AC100/ 240V), frequency (40 KHz), and Power output (45W). This will be for 15 minutes on each abdominal side.

Intervention Type: DEVICE

Whole body vibration

Whole body vibration + Low caloric diet Low caloric diet program (1500 Kcal/ day) for 6 weeks.

Whole body vibration: for 30 minutes/session, 2 sessions/week for 6 weeks as follows:

• The participants will begin with a brief warm-up for 5 minutes by doing deep breathing exercises.
• Then they will stand with feet shoulder-width apart on the platform while holding handrails to maintain balance and stability. They will be instructed to relax and allow the vibrations to pass through her body. This will be applied for 20 minutes per session.
• The vibration will be started with lower settings and gradually will be increased till the desired frequency and amplitude (45 HZ) will be reached.
• After the session will be completed, the participant will be instructed to cool down gradually by doing deep breathing for 5 minutes to help their body to return to a resting state. They will be advised to drink plenty of water to be hydrated and recovered after the WBV session.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adolescent females suffer from abdominal obesity.
• Their ages will be ranged from 17 to 25 years old.
• Their body mass index (BMI) will be ranged from 30 to 35 kg/m2.
• Their waist circumference will be > 88 cm.
• Their WHR will be more than 0.88.

Exclusion Criteria

Females will be excluded from the study if they have:

• Thyroid, hepatic and kidney disorders.
• Diabetes mellitus, coronary artery diseases, hypertension and congestive heart failure.
• Recent abdominal surgical scar or umbilical hernia.
• History of orthopedic implants insertion or cardiac pacemaker implantation.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Christina Samir Harmakes

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azza Kassab

Role: STUDY_CHAIR

Cairo University

Manal El-Shafei

Role: STUDY_DIRECTOR

Cairo University

Mohamed AboEleinen

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Christina yassa, Master

Role: CONTACT

christina.haram@gmail.com

+201228294939

Peter Armanious

Role: CONTACT

peterfayek1985@gmail.com

+201017816200

Other Identifiers

P.T.REC/012/004858

Identifier Type: -

Identifier Source: org_study_id