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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karacan, Bagcilar Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT01310335
First received: March 7, 2011
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  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
Bone Mass
Effects of Vibration
 Device: whole-body vibration (WBV)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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 Bagcilar Training and Research Hospital:

Primary Outcome Measures:
  • Plasma Sclerostin Level [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Karacan, 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
Study First Received: March 7, 2011
Last Updated: February 15, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Bagcilar Training and Research Hospital:
sclerostin
whole-body vibration

Additional relevant MeSH terms:
Raynaud Disease
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013