NCT06202365

Brief Summary

Obesity is a global public-health issue, with rising incidence and prevalence, significant expenditures, and poor results. Obesity has become a worldwide epidemic in both developed and underdeveloped countries. A body mass index (BMI) of 30 kg/m2 is required for class I obesity, a BMI of 35 - 39.9 kg/m2 is required for class II obesity, and a BMI of 40 kg/m2 is required for class III obesity (morbidly obese). Obesity will be the likely situation for the majority of the adult population during the next two decades due to an abundance of calorie-rich food and apathy toward exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

December 31, 2023

Last Update Submit

September 17, 2024

Conditions

Obesity

Keywords

Whole body vibrationTrunk enduranceBalanceObesityFemales

Outcome Measures

Primary Outcomes (1)

  • Sorensen Test

    The participants will be asked to lie prone on the treatment table with their hips and knees extended and their arms crossed over their chest, then placing a strap over the pelvis, knees and ankles for support. Then they will be instructed to raise their upper body off the table until their back were parallel to the floor

    6 weeks

Secondary Outcomes (3)

  • Trunk flexor endurance Test

    6 weeks

  • Single leg test

    6 weeks

  • Dynamic balance

    6 weeks

Study Arms (2)

Group A (WBV Group)

EXPERIMENTAL

A vibrating platform (WBV) will be used in this study with 6 training exercises for 4 minutes, 2 times /week for 6 weeks. Feet should be parallel at shoulder width apart and knees hold constant. WBV sessions were conducted from low to medium-vibration mode

Device: Whole body Vibration

Group B (Sham WBV Group)

SHAM COMPARATOR

They will receive the same intervention while the device turned off for 4 minutes, 2 session/ week for 6 weeks.

Other: Sham Whole body vibration

Interventions

Whole body VibrationDEVICE

A vibrating platform (WBV) will be used in this study with 6 training exercises for 4 minutes, 2 times /week for 6 weeks. Feet should be parallel at shoulder width apart and knees hold constant. WBV sessions were conducted from low to medium-vibration mode

Group A (WBV Group)
Sham Whole body vibrationOTHER

They will receive the same intervention while the device turned off for 4 minutes, 2 times /week for 6 weeks.

Group B (Sham WBV Group)

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale Students
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female students
  • BMI ≥ 30
  • Aged from 18 to 25 years old

You may not qualify if:

  • Pregnancy
  • Musculoskeletal disorders
  • History of spinal surgery
  • Epilepsy
  • Medications that could affect the musculoskeletal system
  • Performing regular exercise of more than 3 times a week
  • Metal plates in the body
  • Ligament sprain
  • Medical history such as cardiovascular disease, or diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesma Morgan Allam

Giza, 12111, Egypt

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hadaya M Eladl, PhD

    Assisstant professor of physical therapy for surgery, Faculty of physical therapy

    STUDY DIRECTOR

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
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

December 31, 2023

First Posted

January 11, 2024

Study Start

December 1, 2023

Primary Completion

May 1, 2024

Study Completion

June 1, 2024

Last Updated

September 19, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)