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Effect of Whole-Body Vibration on Plasma Sclerostin Level (WBV-SCL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310335
First Posted: March 8, 2011
Last Update Posted: February 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
  Purpose

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.


Condition Intervention
Osteopenia Device: whole-body vibration (WBV)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women

Further study details as provided by Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Plasma Sclerostin Level [ Time Frame: 1 month ]
    Change of plasma sclerostin level with whole-body vibration


Enrollment: 15
Study Start Date: April 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Training
The whole-body vibration (WBV) training
Device: whole-body vibration (WBV)
All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.
Other Name: Cyclic mechanical loading

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women,
  • Women with ages varying between 20 and 40 years
  • Right-handed women

Exclusion Criteria:

  • Lower extremity problems

    1. Orthopedic problems: shortness of legs, congenital anomalies, etc.
    2. Joint disease (arthritis, joint prosthesis, etc.)
    3. Other painful pathologies in the lower extremities (fractures, tendinitis,bursitis, etc.)
    4. Circulation problems in the lower extremities
  • Dorsolumbar diseases: Vertebral fract, disc hernias, spondylodiskitis, etc.
  • Systemic disease cases

    1. Systemic bone disease: osteoporosis, osteomalacia, Paget's disease
    2. Hypertension (>135 mmHg systolic, >85 mmHg diastolic)
    3. Heart dis.(coronary dis, conduction/rhythm prob, cardiac pacemaker)
    4. Infectious diseases
    5. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310335


Locations
Turkey
Bagcilar Training & Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Bagcilar Training and Research Hospital
Investigators
Study Chair: ILHAN KARACAN, MD Bagcilar Training & Research Hospital
  More Information

Responsible Party: Ilhan Karacan, Clinical Associated Professor, Chief of Physical Med & Rehab Clinic, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier: NCT01310335     History of Changes
Other Study ID Numbers: BEAH FTR-1
First Submitted: March 7, 2011
First Posted: March 8, 2011
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital:
sclerostin
whole-body vibration

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases