NCT03750799

Brief Summary

This study evaluates whether an increase in the ipsilateral knee flexor muscle strength transfers to the contralateral knee extensors which are not exposed to vibration, when unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half of volunteers the right leg were exposed vibration, while in the other half the right leg were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts, USA) extremity-testing system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

November 18, 2018

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle strength gain of the untrained contralateral quadriceps muscle

    Untrained contralateral quadriceps muscle strength was measured with the Cybex extremity-testing system before and after trial. Unit of this parameter was Nm

    four months

Study Arms (2)

Experimental group

EXPERIMENTAL

Whole body vibration was applied on the right lower extremity.

Device: Whole body vibration

Sham group

SHAM COMPARATOR

Unlike the experimental group, sham vibration was applied to the control group.

Device: Sham vibration

Interventions

Whole body vibration was applied on the right lower extremity in the experimental group.

Experimental group

Sham vibration was applied on the right lower extremity in the Control sham group

Sham group

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men with ages between 20-50 years
  • Being healthy
  • Being volunteer
  • Right-sided dominant

You may not qualify if:

  • Non-cooperative subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • Karacan I, Cidem M, Cidem M, Turker KS. Whole-body vibration induces distinct reflex patterns in human soleus muscle. J Electromyogr Kinesiol. 2017 Jun;34:93-101. doi: 10.1016/j.jelekin.2017.04.007. Epub 2017 Apr 24.

    PMID: 28457998BACKGROUND
  • Karacan I, Cidem M, Yilmaz G, Sebik O, Cakar HI, Turker KS. Tendon reflex is suppressed during whole-body vibration. J Electromyogr Kinesiol. 2016 Oct;30:191-5. doi: 10.1016/j.jelekin.2016.07.008. Epub 2016 Jul 25.

    PMID: 27485766BACKGROUND
  • Cakar HI, Cidem M, Sebik O, Yilmaz G, Karamehmetoglu SS, Kara S, Karacan I, Turker KS. Whole-body vibration-induced muscular reflex: Is it a stretch-induced reflex? J Phys Ther Sci. 2015 Jul;27(7):2279-84. doi: 10.1589/jpts.27.2279. Epub 2015 Jul 22.

    PMID: 26310784BACKGROUND
  • Karamehmetoglu SS, Karacan I, Cidem M, Kucuk SH, Ekmekci H, Bahadir C. Effects of osteocytes on vibration-induced reflex muscle activity in postmenopausal women. Turk J Med Sci. 2014;44(4):630-8.

    PMID: 25551934BACKGROUND
  • Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.

    PMID: 25207162BACKGROUND
  • Cakar HI, Cidem M, Kara S, Karacan I. Vibration paradox and H-reflex suppression: is H-reflex suppression results from distorting effect of vibration? J Musculoskelet Neuronal Interact. 2014 Sep;14(3):318-24.

    PMID: 25198227BACKGROUND

Study Officials

  • Ilhan Karacan, Assoc Prof

    Istanbul Physical Medicine Rehabilitation Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All of the participants were told that the vibration stimulation was performed for muscle strengthening. However, participants had no knowledge about the characteristics of the vibration used for muscle-strength enhancement. Vibration was applied in the experimental group, whereas sham vibration was applied in the Control group. The WBV exercise was performed at different days for the Control and Experimental groups to make them blind to each other's applications.All measurements were made by an independent assessor (isokinetic test laboratory assistant) blinded to the trial allocation.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Experimental group was exposed WBV, Control group was exposed sham WBV
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, Assoc Prof

Study Record Dates

First Submitted

November 18, 2018

First Posted

November 23, 2018

Study Start

November 12, 2018

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations