Effects of whole-body vibration program in vibro-tactile perception threshold in healthy people

ISRCTN	ISRCTN38085825
DOI	https://doi.org/10.1186/ISRCTN38085825
Secondary identifying numbers	2

Submission date: 20/11/2013
Registration date: 18/12/2013
Last edited: 18/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Narcis Gusi
Scientific

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

Email	ngusi@unex.es

Study information

Study design	Single centre single-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Effects of whole-body vibration program in vibro-tactile perception threshold in healthy people: a pilot study
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	03/12/2012
Completion date	21/12/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	24
Key inclusion criteria	1. Under 40 2. Be physically active 3. Link with the University of Extremadura
Key exclusion criteria	1. Having a health problem 2. Being under medication
Date of first enrolment	03/12/2012
Date of final enrolment	21/12/2012

Locations

Countries of recruitment

Spain

Study participating centre

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

Caceres
10003
Spain

Sponsor information

University of Extremadura (Spain)
University/education

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

Website	http://www.unex.es
"ROR"	https://ror.org/0174shg90

Funders

Funder type

Research organisation

AFYCAV group (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan