NCT01419782

Brief Summary

The aim of this study is to investigate effects of femur exposed to unilateral vibration on the rest muscle electrical activity of contralateral hip adductors and contralateral soleus H-reflex in young adult men. This study hypothesize that femur exposed to unilateral vibration may affect the rest muscle electrical activity of contralateral hip adductors. Vibration can effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. It has been showed that bone has an effect on the increase in muscle EMG activity caused by vibration in healthy young adults in a study. In this study, it was reported that vibrations-induced increases in muscle electrical activity of flexor carpi radialis (FCR) was related to ultradistal radius bone mineral content (BMC) and the FCR H-reflex was suppressed or depressed during vibration. This findings were reported to support the assumption that the bone exposed to cyclic mechanical loading may neuronally regulate muscle activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 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

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 7, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

August 17, 2011

Last Update Submit

May 6, 2013

Conditions

Keywords

boneosteocyterest muscle electrical activitywhole-body vibrationsclerostin

Outcome Measures

Primary Outcomes (1)

  • Vibration-induced contralateral muscle electrical activity

    3 month

Study Arms (1)

Whole-body vibration

EXPERIMENTAL

whole body vibration will be applied the right lower limb.

Other: Whole-body vibration

Interventions

Frequency: 40 Hz, vibration amplitude: 2 mm, duration: 60 sec

Also known as: Cyclic mechanical loading
Whole-body vibration

Eligibility Criteria

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

You may qualify if:

  • Age: 20-40 yrs
  • Gender: Male
  • Volunteer
  • Healthy status: Patients having hypoesthesia in his leg and Healthy subjects
  • Dominant hand:Right-handed

You may not qualify if:

  • Bone diseases (osteoporosis, osteomalacia, paget's disease, neoplasm, etc),
  • Systemic diseases (cardiovascular, endocrine, infections etc),
  • Myopathy-tendinopathy
  • Lower limb joint disease
  • Vertigo
  • Obesity (BMI \>30 kg/m2)
  • Professional sportsman
  • Male doing regular sports activities
  • Skin disease in lower limb
  • Non-cooperative subject
  • Hemolysis of blood sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagcilar Training & Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sclerosteosis

Study Officials

  • ILHAN KARACAN, MD

    Bagcilar Training & Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ILHAN KARACAN

Study Record Dates

First Submitted

August 17, 2011

First Posted

August 18, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

May 7, 2013

Record last verified: 2013-05

Locations