NCT04930068

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 7, 2021

Last Update Submit

June 10, 2021

Conditions

Keywords

Ultrasonicaerobic exerciseDiet

Outcome Measures

Primary Outcomes (1)

  • 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

    6 weeks

Secondary Outcomes (1)

  • skin fold caliper

    6 weeks

Study Arms (2)

ultra-sound

EXPERIMENTAL

ultrasonic cavitation applied on abdominal region for 30 minutes, 2 times per week for 6 weeks.

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

Other: low caloric diet

Interventions

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.

aerobic exerciseultra-sound

Eligibility Criteria

Age17 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Their ages were range from 17 to 21 years old.
  • Their body mass index less than 35kg/m2.

You may not qualify if:

  • Females with BMI exceed 35kg/m2.
  • Females have psychological disorders.
  • cardiac diseases.
  • hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy- Cairo University

Giza, Dokki, 12613, Egypt

RECRUITING

MeSH Terms

Interventions

Caloric Restriction

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ghada E Elrefaye, professor

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghada E Elrefaye, professor

CONTACT

Ghada E Elrefaye, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
closed enveloped
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group (A) consisted of 25 females who treated by ultrasonic cavitation, group (B) consisted of 25 females who performed aerobic exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 18, 2021

Study Start

May 1, 2021

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations