Imaging on Core Muscles Function in Patients With Visceral Adiposity

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

device and exercise

About this trial

This is an interventional supportive care trial for Obesity, Abdominal

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Deraya university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

cavitation ultrasonic lipolysis

RUSI guided core muscle exercise

combination of cavitation and RUSI

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

diaphragm excursion

by ultrasound imaging in centimeter

transverse abdominins contraction ratio

by ultrasound imaging in percent

Secondary Outcome Measures

visceral fat thickness

by ultrasound imaging in centimeter

waist circumference

by tape measurement

Full Information

NCT ID

NCT05690659

First Posted

January 9, 2023

Last Updated

September 24, 2023

Sponsor

Deraya University

1. Study Identification

Unique Protocol Identification Number

NCT05690659

Brief Title

Imaging on Core Muscles Function in Patients With Visceral Adiposity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

November 20, 2022 (Actual)

Study Completion Date

January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Deraya University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Abdominal

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cavitation ultrasonic lipolysis

Arm Type

Experimental

Arm Description

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

Arm Title

RUSI guided core muscle exercise

Arm Type

Experimental

Arm Description

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

Arm Title

combination of cavitation and RUSI

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

device and exercise

Intervention Description

cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

Primary Outcome Measure Information:

Title

diaphragm excursion

Description

by ultrasound imaging in centimeter

Time Frame

five weeks

Title

transverse abdominins contraction ratio

Description

by ultrasound imaging in percent

Time Frame

5 weeks

Secondary Outcome Measure Information:

Title

visceral fat thickness

Description

by ultrasound imaging in centimeter

Time Frame

5 weeks

Title

waist circumference

Description

by tape measurement

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Deraya university

City

Minya

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

No

Obesity, Abdominal

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial