Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

June 10, 2021 updated by: Ghada Ebrahim El Refaye, Cairo University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt, 12613

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ultra-sound
ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks.
Other: low caloric diet
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.
EXPERIMENTAL: aerobic exercise
aerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks
Other: low caloric diet
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioelectrical impedance analysis
Time Frame: 6 weeks
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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin fold caliper
Time Frame: 6 weeks
was used to measure the waist circumference and amount of subcutaneous fat when the fold for all females in both groups (A&B)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

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

Investigators

  • Principal Investigator: Ghada E Elrefaye, professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2021

Primary Completion (ANTICIPATED)

July 30, 2021

Study Completion (ANTICIPATED)

July 31, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cairo Un112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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