Protocol summary

Summary
Objective: The aim of this study is to compare the effect whole body vibration on lower limbs functional activity, knee extensors muscles strength and dynamic balance in the healthy athlete and non-athlete subjects. Design: This is a non-randomized clinical trial study with no control group. Setting: 40 healthy students including 20 athletes and 20 non-athlete subjects will participate in this study. Inclusion and Exclusion: The main inclusion criteria are healthy volunteer athlete and non-athlete students aged between 18-30 years old who will refer to Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences. The main exclusion criteria are irregular participation during the training session, any neuromusculoskeletal and cardiopulmonary problems during training session and some problems such as LBP, tumors, migraine, vertigo, DVT, hip, knee and ankle joints deformities and pregnancy. Intervention: Whole body vibration will be applied 6 sessions (3 times per week) for each participant. The frequency of device is 35 Hz and the amplitude 2 mm. Each session will be included 10 sets of vibration training with 1 min. vibration and 1 min. rest between 2 sets. Main Outcome Measures: After intervention, vertical jump height, knee extensors muscles torque and dynamic stability indices will be investigated and compared between athlete and non-athlete participants.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015060222539N1
Registration date: 2015-08-23, 1394/06/01
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-08-23, 1394/06/01
Registrant information
Name
Ziaeddin Safavi Farokhi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
zsafavi@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2015-10-17, 1394/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of whole body vibration on knee extensors strength, dynamic balance and functional activity of lower limb in athlete and non-athlete Subjects
Public title
The effect of whole body vibration on athlete and non-athlete subjects
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Healthy volunteer athletes (football and volleyball players) who participate in their sport 3 sessions per week and non-athlete students aged between 18-30 years old. Exclusion criteria: Irregural participation during the trainnig sessions; any neuromuscular or musculoskeletal and cardiopulmonary problems during training sessions; some problems such as LBP; tumors; migraine; vertigo; DVT; any lower limb joint deformity; pregnancy; lower limbs fracture during last 1 year; any severe trauma in trunk or lower limbs during last 3 months.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan, Kilometer 5 of Damghan Road, Semnan University of Medical Sciences
City
Semnan
Postal code
Approval date
2015-05-19, 1394/02/29
Ethics committee reference number
IR.semums.rec.1394.6

Health conditions studied

1

Description of health condition studied
Injury of knee and lower leg
ICD-10 code
S80-S89
ICD-10 code description
Injury of muscle and tendon at lower leg level

Primary outcomes

1

Description
Vertical Jump Height
Timepoint
Before and immediately after intervention
Method of measurement
CM by Meter

2

Description
Muscle Torque
Timepoint
Before and immediately after intervention
Method of measurement
N/M By isokinetic dynamometer

3

Description
Dynamic Balance
Timepoint
Before and immediately after intervention
Method of measurement
Degree by Biodex Balance System

Secondary outcomes

empty

Intervention groups

1

Description
In athlete group 6 sessions (3 sessions per week) of whole body vibration training will be done. In this study the applied frequency will be 35 Hz and the amplitude will be 2 mm.10 sets of training will be done in each session. Each set will be included 1 minute vibration with 1 minute rest between 2 sets.
Category
Prevention

2

Description
In non-athlete group 6 sessions (3 sessions per week) of whole body vibration training will be done. In this study the applied frequency will be 35 Hz and the amplitude will be 2 mm.10 sets of training will be done in each session. Each set will be included 1 minute vibration with 1 minute rest between 2 sets.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Street address
Mashahir Square, in front of Helal Ahmar
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidipour
Street address
Kilometer 5, Damghan Road
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road, Rehabilitation faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road, Rehabilitation faculty, Semnan University of Medical Science
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziaeddin Safavi Farokhi
Position
Ph.D, Assistant Professor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road, Rehabilitation faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ziasafavi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...