Imaging on Core Muscles Function in Patients With Visceral Adiposity

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Abdominal
• Intervention / Treatment: Other: device and exercise

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:

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Deraya university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diaphragm excursion	by ultrasound imaging in centimeter	five weeks
transverse abdominins contraction ratio	by ultrasound imaging in percent	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visceral fat thickness	by ultrasound imaging in centimeter	5 weeks
waist circumference	by tape measurement	5 weeks

Collaborators and Investigators

• Sponsor: Deraya University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): November 20, 2022
• Study Completion (Actual): January 20, 2023

Study Registration Dates

• First Submitted: January 9, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 24, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: P.T.REC/012/003449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No