Combination of Cryolipolysis and Aerobic Exercise in Reducing Abdominal Fat

NCT05852652 | Completed FDA Device

• 1 other identifier: cryolipolysis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Abdominal Obesity

Keywords

cryolipolysis,low calorie diet and areobic exercise

Outcome Measures

Primary Outcomes (4)

• the waist-to-hip ratio

  by tape measurment

  2 months

• abdominal skin fold

  by fat caliper

  2 months

• body mass index

  by equation of world health organization

  2 months

• fat thickness

  by ultrasonography

  2 months

Study Arms (1)

cryolipolysis and aerobic exercise

EXPERIMENTAL

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

Device: cryolipolysis and aerobic exercise

Interventions

cryolipolysis and aerobic exercise DEVICE

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

cryolipolysis and aerobic exercise

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index of the subjects range from (30-40)kg/m2
• subjects have abdominal adiposity

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Heba Ebrahim Elsayed Mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the principle investigator

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 10, 2023
• Study Start: December 12, 2022
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

EG (1)