Condition category
Not Applicable
Date applied
20/11/2013
Date assigned
18/12/2013
Last edited
18/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Vibrotactile sensitivity is an important parameter in some health conditions. As it seems to be related to, it could be a determinant factor in the risk of falling. In recent years, mechanical vibration has ceased to be seen as harmful to health and is now known as a physical training method. The aim of this study is to analyze the immediate and short term effects that a whole-body vibration program can have on sensitivity vibration and vibro-tactile perception threshold in healthy participants.

Who can participate?
Young healthy volunteers

What does the study involve?
Participants will be randomly allocated to one of two groups: an experimental group (5 sessions of whole-body vibration) and a placebo group (5 sessions of a placebo or dummy interventions: simulation intervention based on device implemented with hidden speaker).

What are the possible benefits and risks of participating?
Possible benefits: decrease vibration threshold (improvement of vibro-tactile sensitivity).
Possible risks: back pain, fatigue and soreness.

Where is the study run from?
Faculty of Sport Sciences of Extremadura University (Spain)

When is study starting and how long is it expected to run for?
From 02/12/2013 to 20/12/2013

Who is funding the study?
AFYCAV group (Spain)

Who is the main contact?
Professor Narcis Gusi
ngusi@unex.es

Trial website

Contact information

Type

Scientific

Primary contact

Prof Narcis Gusi

ORCID ID

Contact details

Av. de la Universidad s/n. Faculty of Sport Science.
Caceres
10003
Spain
ngusi@unex.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Effects of whole-body vibration program in vibro-tactile perception threshold in healthy people: a pilot study

Acronym

Study hypothesis

1. The vibro-tactile threshold is increased immediately after applying a Whole-body vibration session.
2. The vibration threshold decreases after application of a Whole-body vibration program

Ethics approval

Biomedical Ethical Committee of the University of Extremadura, 09 October 2012, ref: 44/2012
Biomedical Ethical Committee of the University of Extremadura, 07 July 2013, ref: 33/2013

Study design

Single centre single-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Whole body vibration in healthy people

Intervention

This study was an intervention of vibratory training program which lasted 2 weeks. The design was a single-blinded randomized control trial with a vibratory training applied to the experimental group and a placebo intervention applied to the control group. The allocation of participants into groups was performed using the random sorting method.

Experimental group: 5 sessions of whole-body vibration.

Control group: 5 sessions of a placebo interventions (hidden speakers)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Vibro-tactile threshold measured before and after of first session, before and after of third session, before and after of fifth session and two days after of last session.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

03/12/2012

Overall trial end date

21/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Under 40
2. Be physically active
3. Link with the University of Extremadura

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Having a health problem
2. Being under medication

Recruitment start date

03/12/2012

Recruitment end date

21/12/2012

Locations

Countries of recruitment

Spain

Trial participating centre

Av. de la Universidad s/n. Faculty of Sport Science.
Caceres
10003
Spain

Sponsor information

Organisation

University of Extremadura (Spain)

Sponsor details

AFYCAV
Av. de la Universidad s/n. Faculty of Sport Science.
Cáceres
10003
Spain

Sponsor type

University/education

Website

http://www.unex.es

Funders

Funder type

Research organisation

Funder name

AFYCAV group (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes