ObesityNCT06202365
Whole Body Vibration in Obese Female Students
A study testing Whole body Vibration in people with Obesity, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whole body Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female students
- BMI ≥ 30
- Aged from 18 to 25 years old
Who cannot join
- 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
Show all 9Show fewer
- Metal plates in the body
- Ligament sprain
- Medical history such as cardiovascular disease, or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Whole body Vibration, Sham Whole body vibration
- Keywords
- Whole body vibration, Trunk endurance, Balance, Obesity, Females
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Sham Whole body vibrationOther
They will receive the same intervention while the device turned off for 4 minutes, 2 times /week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Sham Whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Dec 2023
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Study director, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202365
- Sponsor's protocol ID
- IRB Approval No. 2023-125
- Status last verified
- Dec 2023
- First submitted
- 31 Dec 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Whole Body Vibration on Trunk Endurance and Balance in Obese Female Students
- ClinicalTrials.gov ID
- NCT06202365
- Acronym / sponsor ID
- IRB Approval No. 2023-125
- Conditions
- Obesity
- Keywords
- Whole body vibration, Trunk endurance, Balance, Obesity, Females
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (WBV Group) | Experimental | Device: Whole body VibrationA 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 B (Sham WBV Group) | Sham comparator | Other: Sham Whole body vibrationThey will receive the same intervention while the device turned off for 4 minutes, 2 session/ week for 6 weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female students
- BMI ≥ 30
- Aged from 18 to 25 years old
Key exclusion criteria (9 listed)
- Pregnancy
- Musculoskeletal disorders
- History of spinal surgery
- Epilepsy
- Medications that could affect the musculoskeletal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body VibrationA 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 | Group A (WBV Group) |
| Sham Whole body vibrationThey will receive the same intervention while the device turned off for 4 minutes, 2 times /week for 6 weeks. | Other | Group B (Sham WBV Group) |
Primary outcome
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
3 secondary outcomes
Trunk flexor endurance Test
Time frame: 6 weeks
Single leg test
Time frame: 6 weeks
Dynamic balance
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadaya M Eladl, PhD study director
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body Vibration in people with Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sorensen Test (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.