NCT01310335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 25, 2016

Status Verified

February 1, 2016

Enrollment Period

Same day

First QC Date

March 7, 2011

Last Update Submit

February 23, 2016

Conditions

Keywords

sclerostinwhole-body vibration

Outcome Measures

Primary Outcomes (1)

  • Plasma Sclerostin Level

    Change of plasma sclerostin level with whole-body vibration

    1 month

Study Arms (1)

Training

EXPERIMENTAL

The whole-body vibration (WBV) training

Device: whole-body vibration (WBV)

Interventions

All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.

Also known as: Cyclic mechanical loading
Training

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bone Diseases, MetabolicSclerosteosis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • ILHAN KARACAN, MD

    Bagcilar Training & Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Physical Med & Rehab Clinic

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 8, 2011

Study Start

April 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

February 25, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations