Imaging on Core Muscles Function in Patients With Visceral Adiposity

Sponsor

Deraya University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05690659

Collaborator

(none)

Enrollment

Location

Arms

5.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity, Abdominal	Other: device and exercise	N/A

Detailed 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:

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

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Impact of Rehabilitative Ultrasonography Imaging on Core Muscles Function in Patients With Visceral Adiposity: Randomized Controlled Trail

Actual Study Start Date :

Aug 1, 2022

Actual Primary Completion Date :

Nov 20, 2022

Anticipated Study Completion Date :

Jan 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: cavitation ultrasonic lipolysis on abdomen 2 sesions / week for 10 sessions , Treatment head was griped perpendicular to abdomen, and make slow circular motion with marked pressure.2 sesions / week for 10 sessions	Other: device and exercise cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging
Experimental: RUSI guided core muscle exercise 2 sesions / week for 10 sessions For diaphragm muscle the transducer was placed on the sub costal region to visualize diaphragm muscle on the screen aiming to use US as a visual feedback procedure. instructed to have 5 seconds to contract the diaphragm muscle by deep breathing and hold the contraction. At the end of the 5-second period, the image was saved on the screen, and the measurement of the resultant increase in thickness was performed. Each subject performed a total of 10 contractions (intervention session) For transverse abdominis exercise,. draw in your umbilicus toward the spine without moving back or pelvis, while comfortably breathing in and out," for 10 seconds hold and then 15 seconds rest in between, it was repeated 3 sets of ten while keeping the transducer perpendicular to the surface of the skin in a transverse plane halfway between the ASIS and the lower ribcage along the anterior axillary line	Other: device and exercise cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging
Experimental: combination of cavitation and RUSI combination of cavitation and RUSI 2 sesions / week for 10 sessions	Other: device and exercise cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

Arm

Intervention/Treatment

Experimental: cavitation ultrasonic lipolysis

on abdomen 2 sesions / week for 10 sessions , Treatment head was griped perpendicular to abdomen, and make slow circular motion with marked pressure.2 sesions / week for 10 sessions

Other: device and exercise

cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

Experimental: RUSI guided core muscle exercise

2 sesions / week for 10 sessions For diaphragm muscle the transducer was placed on the sub costal region to visualize diaphragm muscle on the screen aiming to use US as a visual feedback procedure. instructed to have 5 seconds to contract the diaphragm muscle by deep breathing and hold the contraction. At the end of the 5-second period, the image was saved on the screen, and the measurement of the resultant increase in thickness was performed. Each subject performed a total of 10 contractions (intervention session) For transverse abdominis exercise,. draw in your umbilicus toward the spine without moving back or pelvis, while comfortably breathing in and out," for 10 seconds hold and then 15 seconds rest in between, it was repeated 3 sets of ten while keeping the transducer perpendicular to the surface of the skin in a transverse plane halfway between the ASIS and the lower ribcage along the anterior axillary line

Other: device and exercise

cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

Experimental: combination of cavitation and RUSI

combination of cavitation and RUSI 2 sesions / week for 10 sessions

Other: device and exercise

cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

Outcome Measures

Primary Outcome Measures

diaphragm excursion [five weeks]
by ultrasound imaging in centimeter
transverse abdominins contraction ratio [5 weeks]
by ultrasound imaging in percent

Secondary Outcome Measures

visceral fat thickness [5 weeks]
by ultrasound imaging in centimeter
waist circumference [5 weeks]
by tape measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deraya university	Minya		Egypt

Sponsors and Collaborators

Deraya University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deraya University

ClinicalTrials.gov Identifier:

NCT05690659

Other Study ID Numbers:

P.T.REC/012/003449

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Abdominal

Study Results

No Results Posted as of Jan 19, 2023