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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05690659
Other study ID # P.T.REC/012/003449
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date January 20, 2023

Study information

Verified date September 2023
Source Deraya University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of cavitation ultrasonic lipolysis, RUSI guided core muscle exercise and their combination (cavitation ultrasonic lipolysis and RUSI guided core muscles exercise) on diaphragmatic excursion, transverse abdominis activation ratio, visceral fat thickness and waist circumference in patients with visceral adiposity patients with visceral adiposity will be recognized by nutrition specialist. 45 patients were distributed randomly into three groups. The first group will be treated with Cavitation lipolysis twice weekly. The second group was treated with rehabilitative ultrasound imaging (RUSI) guided core muscle exercise. The third group was treated with combination of cavitation and RUSI. patients will be examined with medical ultrasound imaging and tape measurement.


Description:

- Inclusion criteria: Forty five subjects participated in this study. Age of participants ranged from 25 to 45 years. 3. Waist circumference was more than 102 cm for men and 88 cm for women 4. Body mass index (BMI) ranged from 25 to 29.9 (Kg / m2). 5. Subjects hadn't received drugs Exclusion criteria: 1. history of spinal surgery or spinal fracture. 2. Serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer. 3. A history of bronchial asthma or any chest disease. 4. Uncontrolled diabetes or hypertension. 5. Patients with peacemaker or any metal implant on the treated area. 6. Cancer or patient with past history of tumor excision


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 20, 2023
Est. primary completion date November 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 45 Years
Eligibility Inclusion Criteria: - Forty five subjects participated in this study. - Age of participants ranged from 25 to 45 years. - Waist circumference was more than 102 cm for men and 88 cm for women - Body mass index (BMI) ranged from 25 to 29.9 (Kg / m2). - Subjects hadn't received drugs Exclusion Criteria: .history of spinal surgery or spinal fracture. - Serious diseases, such as heart disease, kidney, liver diseases, gastric ulcer or duodenal ulcer. - A history of bronchial asthma or any chest disease. - Uncontrolled diabetes or hypertension. - Patients with peacemaker or any metal implant on the treated area. - Cancer or patient with past history of tumor excision.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
device and exercise
cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

Locations

Country Name City State
Egypt Deraya university Minya

Sponsors (1)

Lead Sponsor Collaborator
Deraya University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary diaphragm excursion by ultrasound imaging in centimeter five weeks
Primary transverse abdominins contraction ratio by ultrasound imaging in percent 5 weeks
Secondary visceral fat thickness by ultrasound imaging in centimeter 5 weeks
Secondary waist circumference by tape measurement 5 weeks
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