OsteopeniaWBV-SCLNCT01310335
Effect of Whole-Body Vibration on Plasma Sclerostin Level
A study testing whole-body vibration (WBV) in people with Osteopenia, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women. Fifteen healthy young adult women are planned to include in this study. All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- whole-body vibration (WBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2011to Apr 2011
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women,
- Women with ages varying between 20 and 40 years
- Right-handed women
Who cannot join
- Lower extremity problems
- Orthopedic problems: shortness of legs, congenital anomalies, etc.
- Joint disease (arthritis, joint prosthesis, etc.)
- Other painful pathologies in the lower extremities (fractures, tendinitis,bursitis, etc.)
- Circulation problems in the lower extremities
- Dorsolumbar diseases: Vertebral fract, disc hernias, spondylodiskitis, etc.
Show all 20Show fewer
- Systemic disease cases
- Systemic bone disease: osteoporosis, osteomalacia, Paget's disease
- Hypertension (>135 mmHg systolic, >85 mmHg diastolic)
- Heart dis.(coronary dis, conduction/rhythm prob, cardiac pacemaker)
- Infectious diseases
- Endocrine diseases (Diabetes mellitus etc)
- Neurological diseases (CNS problems, peripheral neuropathy)
- Menstrual cycle disorders, amenorrhea, lactation, oral contraceptive use
- Cases during the ovulatory period (11-16th day of menses)
- Obesity (BMI >30 kg/m2) or low BMI (BMI <20 kg/m2)
- Vertigo
- Cognitive function disorders
- Women whose blood samples were not taken in the time planned
- Women whose blood samples hemolyzed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training & Research Hospital
Istanbul
About this study
Official title: Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women
The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.
Fifteen healthy young adult women are planned to include in this study. All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. Training duration will be short at the beginning but progressed slowly.
Read more
The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The subjects will be asked to report negative side effects or adverse reactions in their training diary.
Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels will be measured by human sclerostin ELISA kit.
Read the detailed description
Whole-body vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates the osteocytes.
Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.
The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.
- Conditions
- Osteopenia
- Being tested
- whole-body vibration (WBV)
- Keywords
- sclerostin, whole-body vibration
- Medical subject headings
- Bone Diseases, Metabolic, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibration (WBV)Device
Also called Cyclic mechanical loading
All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | The whole-body vibration (WBV) training Receives: Device: whole-body vibration (WBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Sclerostin Level
Change of plasma sclerostin level with whole-body vibration
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Study chair, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310335
- Sponsor's protocol ID
- BEAH FTR-1
- Acronym
- WBV-SCL
- Status last verified
- Feb 2016
- First submitted
- 7 Mar 2011
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women
- ClinicalTrials.gov ID
- NCT01310335
- Acronym / sponsor ID
- WBV-SCL / BEAH FTR-1
- Conditions
- Osteopenia
- Keywords
- sclerostin, whole-body vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Apr 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Mar 2011 (estimated)
- 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.
The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.
Fifteen healthy young adult women are planned to include in this study. All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. Training duration will be short at the beginning but progressed slowly.
The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The subjects will be asked to report negative side effects or adverse reactions in their training diary.
Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels will be measured by human sclerostin ELISA kit.
Detailed description
Whole-body vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates the osteocytes.
Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.
The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Device: whole-body vibration (WBV)The whole-body vibration (WBV) training |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women,
- Women with ages varying between 20 and 40 years
- Right-handed women
Key exclusion criteria (20 listed)
- Lower extremity problems
- Dorsolumbar diseases: Vertebral fract, disc hernias, spondylodiskitis, etc.
- Systemic disease cases
- Neurological diseases (CNS problems, peripheral neuropathy)
- Menstrual cycle disorders, amenorrhea, lactation, oral contraceptive use
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 vibration (WBV)Also: Cyclic mechanical loadingAll cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. | Device | Training |
Primary outcome
Plasma Sclerostin Level
Time frame: 1 month
Change of plasma sclerostin level with whole-body vibration
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 25 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Osteopenia
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
Optimal Meals to Reduce Bone Resorption in Women With Osteopenia
Osteopenia
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
RecruitingObservational study
A Study Evaluating the Performance of Using AI Software and Chest X-rays to Screen for Osteoporosis as Compared to Standard DXA Scans in Patients 50 Years and Older
Osteoporosis, Osteopenia
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.
ILHAN KARACAN, MD study chair
Bagcilar Training & Research Hospital
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 (WBV) in people with Osteopenia, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 20 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 25 Feb 2016. 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 Turkey (Türkiye). 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. 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?
Plasma Sclerostin Level (time frame: 1 month). 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 25 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.