Whole Body Vibration in Obese Female Students

December 31, 2023 updated by: Nesma Morgan Allam, Cairo University

Acute Effect of Whole Body Vibration on Trunk Endurance and Balance in Obese Female Students

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obese and overweight young people swayed at a higher rate than people of normal weight. Two hypotheses have been offered to explain the negative effect of weight on balance control. The first is decreased plantar sensitivity as a result of hyper-activation of plantar mechanoreceptors caused by the constant pressure of supporting a heavy burden. The second theory is that there is a higher mechanical demand owing to the big body mass itself, as well as a non-negligible amount of body mass further away from the axis of rotation (i.e., ankle joint in an inverted pendulum model) that creates a higher gravitational torque. As a result, in order to maintain an upright posture, the gravitational torque that accelerates the body must be opposed by muscle torques.

WBV is a mechanical stimulation characterized by oscillatory motion supplied from a platform to the entire body. The current devices employ two distinct systems: (a) a vertical vibration, in which the entire plate oscillates uniformly up and down with only a vertical translation; and (b) reciprocating vertical displacements on the left and right sides of a fulcrum, which increases the lateral accelerations. WBV training includes biomechanical characteristics such as body position, amplitude, frequency, magnitude, and duration.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt, 12111
        • Recruiting
        • Nesma Morgan Allam
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (WBV Group)
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
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
Sham Comparator: Group B (Sham WBV Group)
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
They will receive the same intervention while the device turned off for 4 minutes, 2 times /week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sorensen Test
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic balance
Time Frame: 6 weeks
the Biodex Balance System (BBS) SD (12.1-inch [30.7-cm] display, 115 VAC; Biodex Medical Systems Inc., Shirley, NY, USA). The BBS measures stability indices, which represent the variance of foot platform displacement in degrees for motion in different planes. The platform is fixable and movable.
6 weeks
Trunk flexor endurance Test
Time Frame: 6 weeks
The participants will be asked to maintain supine position on the examination table. The lower extremities will be positioned comfortably with the knees flexed, and the feet up. The arms will be placed over the chest or behind the head 6 without pulling on the neck. They will be instructed to perform a partial or full sit-up, engaging the trunk flexors to lift the upper body off the surface.
6 weeks
Single leg test
Time Frame: 6 weeks
for assessment of static balance, the participants will be asked to stand on the dominant leg with their arms crossed over the chest and closed eyes. Then the time will be counted while maintaining this position.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Director: Hadaya M Eladl, PhD, Assisstant professor of physical therapy for surgery, Faculty of physical therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

December 31, 2023

First Submitted That Met QC Criteria

December 31, 2023

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

December 31, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB Approval No. 2023-125

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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