Assessment of prophylactic effect of local vibration on fatigue
Design
A concealed, randomized, blinded, sham controlled clinical trial with 30 patients, enrolled between October 2016 and September 2017.
Settings and conduct
The experiment was conducted at the Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences. Thesubjects were not aware of the be on or off vibration , and the results were analyzed by someone else.
Participants/Inclusion and exclusion criteria
Non athletics and healthy men 18- 25 years old
Intervention groups
Using of Local vibration with 50 frequency in 2 minutes
Main outcome variables
Electromyography findings: Median Frequency, Root Mean square
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090228001719N7
Registration date:2018-07-20, 1397/04/29
Registration timing:retrospective
Last update:2018-07-20, 1397/04/29
Update count:0
Registration date
2018-07-20, 1397/04/29
Registrant information
Name
khadije Otadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 6134
Email address
k_otadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-20, 1396/03/30
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effects of local vibration on quadriceps muscle fatigue in 18-25 years old men
Public title
Effect of vibration on prevention of fatigue
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy- non athletic subjects
age: 18-25
Exclusion criteria:
Disorders or surgery in lower limb
Athletic subjects
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization by removing sealed envelopes that inside the envelopes written " vibration" or " no vibration" word, and people were asked to remove one of the envelopes.
If the envelope was removed had the word "without vibration", the person in the placebo group And vice versa.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participant were blinded and they did not know what to do if they were effected by vibration or not.
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Seiences
Street address
Keshavarz Blv, Qudes Sreet
City
Tehran
Province
Tehran
Postal code
1419934146
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4093
Health conditions studied
1
Description of health condition studied
Healthy- non athletic persons
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
MVC: Maximum Voluntary contraction and Electromyography Findings
Timepoint
Immediately after intervention
Method of measurement
With dynamometer and electromyography measurement
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The local vibration was used at a 50 Hz for 2 minutes on the quadriceps muscle, while the EMG activity of the muscle was recorded.
Category
Prevention
2
Description
"Control group:" In this group, local vibration used in placebo manner over the quadriceps and simultaneously electromyography activity recorded.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation of Shahid Beheshti Medical sceince
Full name of responsible person
Khadijeh Otadi
Street address
Enghlab Ave, Pich e Shemiran, Faculty of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirali Sohrabpour
Street address
Keshavarz Blvd.-Ghodss Street-Nbash- Central University
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 8163 3786
Email
k_otadi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Enghelab, Pich Shemiran
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation, Pich Shemiran, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Khadijeh Otadi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
faculty of Rehabilitation, Pich e Shemiran, Enghelab Avenue,
City
Tehran
Province
Tehran
Postal code
1419934146
Phone
+98 21 7753 3939
Email
k_otadi@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available