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

Primary Purpose

Osteopenia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
whole-body vibration (WBV)
Sponsored by
Bagcilar Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteopenia focused on measuring sclerostin, whole-body vibration

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bagcilar Training & Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training

Arm Description

The whole-body vibration (WBV) training

Outcomes

Primary Outcome Measures

Plasma Sclerostin Level
Change of plasma sclerostin level with whole-body vibration

Secondary Outcome Measures

Full Information

First Posted
March 7, 2011
Last Updated
February 23, 2016
Sponsor
Bagcilar Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01310335
Brief Title
Effect of Whole-Body Vibration on Plasma Sclerostin Level
Acronym
WBV-SCL
Official Title
Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bagcilar Training and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
Keywords
sclerostin, whole-body vibration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Experimental
Arm Description
The whole-body vibration (WBV) training
Intervention Type
Device
Intervention Name(s)
whole-body vibration (WBV)
Other Intervention Name(s)
Cyclic mechanical loading
Intervention Description
All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.
Primary Outcome Measure Information:
Title
Plasma Sclerostin Level
Description
Change of plasma sclerostin level with whole-body vibration
Time Frame
1 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy women, Women with ages varying between 20 and 40 years Right-handed women Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ILHAN KARACAN, MD
Organizational Affiliation
Bagcilar Training & Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bagcilar Training & Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Whole-Body Vibration on Plasma Sclerostin Level

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