NCT05690659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

January 9, 2023

Last Update Submit

September 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • diaphragm excursion

    by ultrasound imaging in centimeter

    five weeks

  • transverse abdominins contraction ratio

    by ultrasound imaging in percent

    5 weeks

Secondary Outcomes (2)

  • visceral fat thickness

    5 weeks

  • waist circumference

    5 weeks

Study Arms (3)

cavitation ultrasonic lipolysis

EXPERIMENTAL

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

RUSI guided core muscle exercise

EXPERIMENTAL

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

combination of cavitation and RUSI

EXPERIMENTAL

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

Other: device and exercise

Interventions

cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging

RUSI guided core muscle exercisecavitation ultrasonic lipolysiscombination of cavitation and RUSI

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deraya university

Minya, Egypt

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Exercise

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 19, 2023

Study Start

August 1, 2022

Primary Completion

November 20, 2022

Study Completion

January 20, 2023

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations