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出境医 / 临床实验 / Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females

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.

Condition or disease Intervention/treatment Phase
Ultrasonic Other: low caloric diet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.
Masking: Single (Outcomes Assessor)
Masking Description: closed enveloped
Primary Purpose: Treatment
Official Title: Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
Actual Study Start Date : May 1, 2021
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 31, 2021
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   17 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
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Contact: Ghada E Elrefaye, professor +201005572715 ext 02 ghadaebrahim2000@gmail.com
Contact: Ghada E Elrefaye, lecturer +201005572715 ext 02 ghadaebrahim2000@gmail.com

Locations
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Egypt
Faculty of physical therapy- Cairo University Recruiting
Giza, Dokki, Egypt, 12613
Contact: ghada eb elrefaye, professor    01005572715 ext 002    ghada.ibrahim2011@yahoo.com   
Contact: Ghada E Elrefaye, lecturer    +201005572715 ext 02    ghadaebrahim2000@gmail.com   
Sponsors and Collaborators
Cairo University
Ghada ebrahim El Refaye - Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Egypt
Investigators
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Principal Investigator: Ghada E Elrefaye, professor Cairo University
Tracking Information
First Submitted Date  ICMJE June 7, 2021
First Posted Date  ICMJE June 18, 2021
Last Update Posted Date June 18, 2021
Actual Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021) 		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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021) 		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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
Official Title  ICMJE Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.
Masking: Single (Outcomes Assessor)
Masking Description:
closed enveloped
Primary Purpose: Treatment
Condition  ICMJE Ultrasonic
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: ultra-sound
    ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks.
    Intervention: Other: low caloric diet
  • Experimental: aerobic exercise
    aerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks
    Intervention: Other: low caloric diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2021) 		40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 17 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ghada E Elrefaye, professor +201005572715 ext 02 ghadaebrahim2000@gmail.com
Contact: Ghada E Elrefaye, lecturer +201005572715 ext 02 ghadaebrahim2000@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04930068
Other Study ID Numbers  ICMJE Cairo Un112
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ghada Ebrahim El Refaye, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Ghada ebrahim El Refaye - Department of Physical Therapy for Women's Health, Faculty of Physical Therapy, Cairo University, Egypt
Investigators  ICMJE
Principal Investigator: Ghada E Elrefaye, professor Cairo University
PRS Account Cairo University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP