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Combination of Cryolipolysis and Aerobic Exercise in Reducing Abdominal Fat

Primary Purpose

Abdominal Obesity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
cryolipolysis and aerobic exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity focused on measuring cryolipolysis,low calorie diet and areobic exercise

Eligibility Criteria

35 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Body mass index of the subjects range from (30-40)kg/m2 subjects have abdominal adiposity Exclusion Criteria: patients with liver and kidney diseases patients who have sensitivity to cold patients who have auto-immune disease patients after caesarean section impaired peripheral circulation Raynauds disease pregnant or lactating women within 6 months paroxysmal cold hemogobulinemia individuals who had metabolic derangement such as type 2 dibetes

Sites / Locations

  • Heba Ebrahim Elsayed Mohamed

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cryolipolysis and aerobic exercise

Arm Description

in this arm we combined between Three Max cool shaping Cryolipolysis device (ESM-8l00MO; EunSung global, Korea) was utilised. Vacuum controllable heads with cold temperatures ranging from (-10to 5)°C were adjusted according to each patient's tolerance, after careful patient sensation examination and vital sign evaluation before and after each session ,they got two sessions and walked from 30 to 60 minutes in nearby park.Two Cryolipolysis treatments totaling 45 minutes each were administered to each patient in the experimental group at the hypogastrium region, 5 cm below the umbilicus, using an anti-freezing membrane to prevent cold burn, in order to conduct the treatment

Outcomes

Primary Outcome Measures

the waist-to-hip ratio
by tape measurment
abdominal skin fold
by fat caliper
body mass index
by equation of world health organization
fat thickness
by ultrasonography

Secondary Outcome Measures

Full Information

First Posted
April 23, 2023
Last Updated
May 2, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05852652
Brief Title
Combination of Cryolipolysis and Aerobic Exercise in Reducing Abdominal Fat
Official Title
The Effect of Combination Between Cryolipolysis and Aerobic Exercise in Reducing Abdominal Adiposity in Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
February 22, 2023 (Actual)
Study Completion Date
February 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
The purpose of the study is To investigate the adding effect of Cryolipolysis to aerobic exercise with low caliorie diet on waist-to-hip ratio , ultrasonography, body mass index and skin fold of subcutaneous fat tissue in abdominal adiposity in obese subjects
Detailed Description
Obesity is a serious disease marked by an increase in body weight of at least 20% over the ideal weight due to an accumulation of body fat. The prevalence of obesity has hit epidemic levels over the past few decades, and numerous obesity-related illnesses, including heart conditions, certain types of cancer, and diabetes, have risen concurrently. Weight loss through lifestyle modification, including a hypocaloric diet and/or increased physical exercise, along with behavioural techniques to support these changes, is the basis for treating or preventing these diseases through therapeutic intervention. Such methods rarely result in an obese person reaching a normal body weight because the typical weight reduction from lifestyle change is between 5 and 10% of baseline weight. Recently, studies have used numerous devices, including cavitation, radiofrequency, cryolypolysis, and other many devices, according to the World Health Organization, to solve this issue. The FDA has approved the cryolipolysis device for cutaneous cooling as well as a number of other uses. Cryolipolysis is a novel non-invasive technique for the selective reduction of fat cells with controlled, localised cooling. Clinicians use the waist measurement and waist-to-hip ratio to assess abdominal obesity. These actions have a clear correlation to many vascular diseases, including atherosclerosis and the risk of developing acute coronary syndromes. Typically, low-calorie diets are low in fat ( 30% of energy intake), high in carbohydrates (55-60% of total daily energy consumption), and energy-reduced (deficit of 2100-4200 kJ/d: ) minimum of 4200-5040 kJ/d for women and 5040- 5880 kJ/d for men) Due to the acutely high energy cost and ability to increase fat utilization, aerobic exercise is frequently recommended in conjunction with calorie restriction. Numerous studies examined the effects of modest caloric restriction alone or in combination with aerobic exercise.According to studies, a walk/jog programme enhanced body fat reduction compared to a group that only followed a diet. There is a gap in the literature regarding combining cryolipolysis and aerobic exercise for losing weight, particularly abdominal adiposity, despite the fact that numerous studies have supported the efficacy of each on weight loss. Therefore, the goal of this research is to ascertain whether losing abdominal adiposity would be more successful when cryolipolysis and aerobic exercise were combined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity
Keywords
cryolipolysis,low calorie diet and areobic exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cryolipolysis and aerobic exercise
Arm Type
Experimental
Arm Description
in this arm we combined between Three Max cool shaping Cryolipolysis device (ESM-8l00MO; EunSung global, Korea) was utilised. Vacuum controllable heads with cold temperatures ranging from (-10to 5)°C were adjusted according to each patient's tolerance, after careful patient sensation examination and vital sign evaluation before and after each session ,they got two sessions and walked from 30 to 60 minutes in nearby park.Two Cryolipolysis treatments totaling 45 minutes each were administered to each patient in the experimental group at the hypogastrium region, 5 cm below the umbilicus, using an anti-freezing membrane to prevent cold burn, in order to conduct the treatment
Intervention Type
Device
Intervention Name(s)
cryolipolysis and aerobic exercise
Intervention Description
the patients in this arm adjusted low calorie diet . According to the Recommended Dietary Intake (RDI), the low-calorie diet plan with three carefully calculated meals had a balanced macronutrient quantity of carbohydrate and protein, was low in fat, and was abundant in fruits, vegetables, and dietary fibres. they got two cryolipolysis sessions,one session in the month ,they got two sessions in two months,then took our outcome measures with walking 60 minutes in the park
Primary Outcome Measure Information:
Title
the waist-to-hip ratio
Description
by tape measurment
Time Frame
2 months
Title
abdominal skin fold
Description
by fat caliper
Time Frame
2 months
Title
body mass index
Description
by equation of world health organization
Time Frame
2 months
Title
fat thickness
Description
by ultrasonography
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index of the subjects range from (30-40)kg/m2 subjects have abdominal adiposity Exclusion Criteria: patients with liver and kidney diseases patients who have sensitivity to cold patients who have auto-immune disease patients after caesarean section impaired peripheral circulation Raynauds disease pregnant or lactating women within 6 months paroxysmal cold hemogobulinemia individuals who had metabolic derangement such as type 2 dibetes
Facility Information:
Facility Name
Heba Ebrahim Elsayed Mohamed
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Combination of Cryolipolysis and Aerobic Exercise in Reducing Abdominal Fat

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