NCT07307898

Brief Summary

The purpose of this study is to compare the effects of ultrasound cavitation and whole-body electromyostimulation (WB-EMS) on inflammatory markers in individuals with central obesity.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2026

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

August 26, 2025

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inflammatory Markers

    Measurement of changes in levels of Tumor Necrosis Factor-alpha (TNF-alpha), and Interleukin-6 (IL-6) using ELISA (Enzyme-Linked Immunosorbent Assay) kits.

    3 Monthes

Secondary Outcomes (3)

  • Waist Circumference

    3 Monthes

  • Body Weight

    3 Monthes

  • Body Mass Index (BMI)

    3 Monthes

Study Arms (3)

group A (Study group)

EXPERIMENTAL

Participants in this cohort were administered localized ultrasound cavitation treatments. Each session was approximately 30 minutes in duration, with treatments scheduled twice a week. In addition, participants received mediterranean diet

Device: cavitation, whole body electromyostimulation

group B (Study group)

EXPERIMENTAL

: Participants assigned to this cohort underwent whole- body electromyostimulation (WB-EMS) therapy. These sessions were 20 minutes long, also occurring twice weekly. Participants also received mediterranean diet.

Device: cavitation, whole body electromyostimulation

Group C (Control Group)

SHAM COMPARATOR

Participants in this control group receive mediterranean diet. Additionally, they participated in all assessment procedures, ensuring a comprehensive comparative analysis.

Device: cavitation, whole body electromyostimulation

Interventions

The duration of the study was set for 12 weeks. Assessments were meticulously conducted at both the baseline and the conclusion of the study period to evaluate outcomes across the different groups.

Group C (Control Group)group A (Study group)group B (Study group)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-50 years.
  • Individuals diagnosed with central obesity, defined as a waist circumference greater than 102 cm in men and 88 cm in women.
  • Participants with a stable body weight for at least three months prior to the study.
  • No engagement in regular physical activity or weight loss programs in the past six months.
  • Willingness to adhere to study protocols and attend all scheduled sessions.

You may not qualify if:

  • Individuals with chronic diseases other than obesity-related conditions, such as cardiovascular disease, diabetes, or severe hypertension.
  • Pregnant or lactating women.
  • Individuals with implanted electronic devices (e.g., pacemakers).
  • Participants with dermatological conditions or skin infections in the treatment area.
  • Individuals undergoing medication that may affect fat metabolism or inflammatory markers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Qalyubia Governorate, 13611, Egypt

Location

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

August 26, 2025

First Posted

December 29, 2025

Study Start

September 5, 2024

Primary Completion

November 5, 2024

Study Completion

January 4, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations