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Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

Primary Purpose

Ultrasonic

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

low caloric diet

About this trial

This is an interventional treatment trial for Ultrasonic focused on measuring Ultrasonic, aerobic exercise, Diet

Eligibility Criteria

17 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Their ages were range from 17 to 21 years old.
Their body mass index less than 35kg/m2.

Exclusion Criteria:

Females with BMI exceed 35kg/m2.
Females have psychological disorders.
cardiac diseases.
hypertension

Sites / Locations

Faculty of physical therapy- Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ultra-sound

aerobic exercise

Arm Description

ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks.

aerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks

Outcomes

Primary Outcome Measures

Bioelectrical impedance analysis

was used to estimate body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Most body water is stored in muscle in both groups A and B

Secondary Outcome Measures

skin fold caliper

was used to measure the waist circumference and amount of subcutaneous fat when the fold for all females in both groups (A&B)

Full Information

NCT ID

NCT04930068

First Posted

June 7, 2021

Last Updated

June 10, 2021

Sponsor

Cairo University

Collaborators

Ghada ebrahim El Refaye - Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Egypt

1. Study Identification

Unique Protocol Identification Number

NCT04930068

Brief Title

Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

Official Title

Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 1, 2021 (Actual)

Primary Completion Date

July 30, 2021 (Anticipated)

Study Completion Date

July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

Collaborators

Ghada ebrahim El Refaye - Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study was to determine the effect of ultrasonic cavitation on abdominal obesity in females. Fifty volunteer females with abdominal obesity participated in the study.

Detailed Description

The purpose of this study was to determine the effectiveness of ultrasonic cavitation on abdominal obesity in adolescent females. Fifty volunteer females with abdominal obesity participated in the study. Group (A) consisted of 25 females who treated by ultrasonic cavitation on abdominal region for 30 minutes and aerobic exercises for 30 minutes, 2 times per week for 6 weeks ; group (B) consisted of 25 females who performed aerobic exercise and low caloric diet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ultrasonic

Keywords

Ultrasonic, aerobic exercise, Diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.

Masking

Outcomes Assessor

Masking Description

closed enveloped

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ultra-sound

Arm Type

Experimental

Arm Description

ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks.

Arm Title

aerobic exercise

Arm Type

Experimental

Arm Description

aerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks

Intervention Type

Other

Intervention Name(s)

low caloric diet

Intervention Description

A low-calorie diet is a structured eating plan that restricts daily caloric intake, commonly for weight loss. Following a low-calorie diet typically means consuming around 1,200 to 1,500 calories per day, which creates a calorie deficit that can lead to weight loss. A low-calorie diet can be effective, but it requires a lot of discipline to work and be safe.

Primary Outcome Measure Information:

Title

Bioelectrical impedance analysis

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

skin fold caliper

Description

was used to measure the waist circumference and amount of subcutaneous fat when the fold for all females in both groups (A&B)

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Their ages were range from 17 to 21 years old. Their body mass index less than 35kg/m2. Exclusion Criteria: Females with BMI exceed 35kg/m2. Females have psychological disorders. cardiac diseases. hypertension

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ghada E Elrefaye, professor

Phone

+201005572715

Ext

ghadaebrahim2000@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ghada E Elrefaye, lecturer

Phone

+201005572715

Ext

ghadaebrahim2000@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ghada E Elrefaye, professor

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of physical therapy- Cairo University

City

Giza

State/Province

Dokki

ZIP/Postal Code

12613

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ghada eb elrefaye, professor

Phone

01005572715

Ext

002

ghada.ibrahim2011@yahoo.com

First Name & Middle Initial & Last Name & Degree

Ghada E Elrefaye, lecturer

Phone

+201005572715

Ext

ghadaebrahim2000@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

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Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

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