Effect of Whole-Body Vibration on Plasma Sclerostin Level

Osteopenia Clinical Trial

— WBV-SCL  

Official title:

Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310335
• Other study ID #: BEAH FTR-1
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: February 23, 2016
• Start date: April 2011
• Est. completion date: April 2011

Study information

• Verified date: February 2016
• Source: Bagcilar Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Osteopenia

Intervention

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.

Locations

Country	Name	City	State
Turkey	Bagcilar Training & Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bagcilar Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Sclerostin Level	Change of plasma sclerostin level with whole-body vibration	1 month	No