Obesity, AbdominalNCT05690659
Imaging on Core Muscles Function in Patients With Visceral Adiposity
A study testing device and exercise in people with Obesity, Abdominal, run by Deraya University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- device and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 20 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- .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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Obesity, Abdominal
- Being tested
- device and exercise
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
device and exerciseOther
cavitation ultrasonic device therapeutic exercise guided ultrasonography imaging
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: device and exercise |
| combination of cavitation and RUSI | Experimental | combination of cavitation and RUSI 2 sesions / week for 10 sessions Receives: Other: device and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
diaphragm excursion
by ultrasound imaging in centimeter
Measured: five weeks
transverse abdominins contraction ratio
by ultrasound imaging in percent
Measured: 5 weeks
Secondary outcomes (2)
visceral fat thickness
by ultrasound imaging in centimeter
Measured: 5 weeks
waist circumference
by tape measurement
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start1 Aug 2022
- Primary completion20 Nov 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deraya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690659
- Sponsor's protocol ID
- P.T.REC/012/003449
- Status last verified
- Sep 2023
- First submitted
- 9 Jan 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rehabilitative Ultrasonography Imaging on Core Muscles Function in Patients With Visceral Adiposity: Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05690659
- Acronym / sponsor ID
- P.T.REC/012/003449
- Conditions
- Obesity, Abdominal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Deraya UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cavitation ultrasonic lipolysis | Experimental | Other: device and exerciseon 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 |
| RUSI guided core muscle exercise | Experimental | Other: device and exercise2 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 | Experimental | Other: device and exercisecombination of cavitation and RUSI 2 sesions / week for 10 sessions |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- .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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| device and exercisecavitation ultrasonic device therapeutic exercise guided ultrasonography imaging | Other | RUSI guided core muscle exercise, cavitation ultrasonic lipolysis, combination of cavitation and RUSI |
Primary outcome
diaphragm excursion
Time frame: five weeks
by ultrasound imaging in centimeter
transverse abdominins contraction ratio
Time frame: 5 weeks
by ultrasound imaging in percent
2 secondary outcomes
visceral fat thickness
Time frame: 5 weeks
waist circumference
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing device and exercise in people with Obesity, Abdominal, run by Deraya University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diaphragm excursion (time frame: five weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.