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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202365
Other study ID # IRB Approval No. 2023-125
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date June 1, 2024

Study information

Verified date December 2023
Source Cairo University
Contact Nesma M Allam, PhD
Phone +201281968332
Email dr.nesma2011@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 1, 2024
Est. primary completion date May 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Egypt Nesma Morgan Allam Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Trunk flexor endurance Test 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
Secondary Single leg test 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
Secondary Dynamic balance 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
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