UltrasonicNCT04930068
Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
A study testing low caloric diet in people with Ultrasonic, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to determine the effect of ultrasonic cavitation on abdominal obesity in females. Fifty volunteer females with abdominal obesity participated in the study. Read more about this study
- Who is it for?
- Ages 17 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ultrasonic
- What is being tested?
- low caloric diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2021to 31 Jul 2021
- 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 17 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Their ages were range from 17 to 21 years old.
- Their body mass index less than 35kg/m2.
Who cannot join
- Females with BMI exceed 35kg/m2.
- Females have psychological disorders.
- cardiac diseases.
- hypertension
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy- Cairo University
Giza, Dokki, 12613
ghada eb elrefaye, professor, 01005572715 ext. 002, ghada.ibrahim2011@yahoo.com
Ghada E Elrefaye, lecturer, +201005572715 ext. 02, ghadaebrahim2000@gmail.com
About this study
The purpose of this study was to determine the effect of ultrasonic cavitation on abdominal obesity in females. Fifty volunteer females with abdominal obesity participated in the study.
Read the detailed description
The purpose of this study was to determine the effectiveness of ultrasonic cavitation on abdominal obesity in adolescent females. Fifty volunteer females with abdominal obesity participated in the study.
Group (A) consisted of 25 females who treated by ultrasonic cavitation on abdominal region for 30 minutes and aerobic exercises for 30 minutes, 2 times per week for 6 weeks ; group (B) consisted of 25 females who performed aerobic exercise and low caloric diet.
- Conditions
- Ultrasonic
- Being tested
- low caloric diet
- Keywords
- Ultrasonic, aerobic exercise, Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low caloric dietOther
A low-calorie diet is a structured eating plan that restricts daily caloric intake, commonly for weight loss. Following a low-calorie diet typically means consuming around 1,200 to 1,500 calories per day, which creates a calorie deficit that can lead to weight loss. A low-calorie diet can be effective, but it requires a lot of discipline to work and be safe.
| Study group | Role | What they receive |
|---|---|---|
| ultra-sound | Experimental | ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks. Receives: Other: low caloric diet |
| aerobic exercise | Experimental | aerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks Receives: Other: low caloric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioelectrical impedance analysis
was used to estimate body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Most body water is stored in muscle in both groups A and B
Measured: 6 weeks
Secondary outcomes (1)
skin fold caliper
was used to measure the waist circumference and amount of subcutaneous fat when the fold for all females in both groups (A\&B)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 May 2021
- Primary completion30 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonicStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada Ebrahim El Refaye, Cairo University
- Investigators
- Ghada E Elrefaye, professor, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930068
- Sponsor's protocol ID
- Cairo Un112
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 18 Jun 2021
- 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 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Cavitation on Abdominal Obesity in Adolescent Females
- ClinicalTrials.gov ID
- NCT04930068
- Acronym / sponsor ID
- Cairo Un112
- Conditions
- Ultrasonic
- Keywords
- Ultrasonic, aerobic exercise, Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 18 Jun 2021 (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 was to determine the effect of ultrasonic cavitation on abdominal obesity in females. Fifty volunteer females with abdominal obesity participated in the study.
Detailed description
The purpose of this study was to determine the effectiveness of ultrasonic cavitation on abdominal obesity in adolescent females. Fifty volunteer females with abdominal obesity participated in the study.
Group (A) consisted of 25 females who treated by ultrasonic cavitation on abdominal region for 30 minutes and aerobic exercises for 30 minutes, 2 times per week for 6 weeks ; group (B) consisted of 25 females who performed aerobic exercise and low caloric diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.
| Arm | Type | Receives |
|---|---|---|
| ultra-sound | Experimental | Other: low caloric dietultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks. |
| aerobic exercise | Experimental | Other: low caloric dietaerobic exercises through treadmill (60-70% of VO2 max.) for 30 minutes, 2 times per week for 6 weeks |
Who may qualify
- Ages
- 17 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Their ages were range from 17 to 21 years old.
- Their body mass index less than 35kg/m2.
Key exclusion criteria (4 listed)
- Females with BMI exceed 35kg/m2.
- Females have psychological disorders.
- cardiac diseases.
- hypertension
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 |
|---|---|---|
| low caloric dietA low-calorie diet is a structured eating plan that restricts daily caloric intake, commonly for weight loss. Following a low-calorie diet typically means consuming around 1,200 to 1,500 calories per day, which creates a calorie deficit that can lead to weight loss. A low-calorie diet can be effective, but it requires a lot of discipline to work and be safe. | Other | aerobic exercise, ultra-sound |
Primary outcome
Bioelectrical impedance analysis
Time frame: 6 weeks
was used to estimate body composition, in particular body fat and muscle mass, where a weak electric current flows through the body and the voltage is measured in order to calculate impedance (resistance) of the body. Most body water is stored in muscle in both groups A and B
1 secondary outcome
skin fold caliper
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- 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.
Ghada E Elrefaye, professor principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low caloric diet in people with Ultrasonic, run by Cairo 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghada E Elrefaye, professor (+201005572715 ext. 02, ghadaebrahim2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioelectrical impedance analysis (time frame: 6 weeks). 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 18 Jun 2021.