Clinical trial NCT01310335: Effect of Whole-Body Vibration on Plasma Sclerostin Level
Official title: Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Keywords: sclerostin
whole-body vibration
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2011-03-08
Enrollment: 15
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Plasma Sclerostin Level
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Training & Research Hospital
Study officials:
affiliation: Bagcilar Training & Research Hospital
name: ILHAN KARACAN, MD
role: STUDY_CHAIR
References: