NCT06024018

Brief Summary

high intensity focused electromagnetic technology's secondary effects are observed in the fat (adipose). within 8 h of a treatment session, apoptotic levels in adipose increased 91.7%.8 In addition, after the application of the high intensity electromagnetic technique, there is an increase in the rapid release of free fatty acids, so it can be used in weight loss

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

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

June 1, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

August 29, 2023

Last Update Submit

September 4, 2023

Conditions

Central Obesity

Outcome Measures

Primary Outcomes (1)

  • subcutaenous abdominal fat thickness

    it will be measured using ultrasonography

    12 weeks

Secondary Outcomes (11)

  • visceral abdominal fat thickness

    12 weeks

  • body mass index

    12 weeks

  • waist circumference

    12 weeks

  • cortisol

    12 weeks

  • high density lipoprotein

    12 weeks

  • +6 more secondary outcomes

Study Arms (2)

first group

EXPERIMENTAL

thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months

Device: high intensity electromagnetic technology device, diet restriction, and walking

second group

ACTIVE COMPARATOR

thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.

Behavioral: diet restriction and walking

Interventions

high intensity electromagnetic technology device, diet restriction, and walkingDEVICE

thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months. Also they will undergo high intensity electromagnetic technique (40 minutes for every session) on abdomen of males which will be 3 sessions per week for 3 months

first group
diet restriction and walkingBEHAVIORAL

thirty obese males (30 males) will undergo dietary caloric restriction and will be instructed to walk 10,000 continuous steps every day using the pedometer application for 3 months.

second group

Eligibility Criteria

Age40 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men with central obesity
  • BMI 30-34.9 kg/m2

You may not qualify if:

  • metabolic /cardiovascular, pulmonary illnesses, musculoskeletal/neurological illness, autoimmune/psychological illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Walking

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

ebtahal ATEF RAMADAN Afya

CONTACT

02 1024666329dr.ebtehalpt@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 5, 2023

Study Start

June 1, 2022

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

EG(1)