Protocol summary

Summary
This study is a single blind, single center, randomized clinical trial. Unaccustomed physical activity, specially eccentric exercise like downhill running, plyometric and strengthening exercises cause pain and irritation after exercise which are generally known as Delayed Onset Muscle Soreness (DOMS). Volunteers which are university students will be randomly allocated in control and intervention groups (each group=26). At the beginning of the first session, height, weight and age will be asked. Students in both groups will walk on the treadmill for 5 minutes with the speed of 3 km/h to warm up. To introduce DOMS, participants will walk on the treadmill for 30 minutes at the speed of 4 km/h and slope will be increased to 10 gradually. Participants in intervention group will receive whole body vibration treatment and control group will walk on the treadmill for 5 more minutes with no grade at the speed of 3 km/h. The outcome measurements are pain, dominant thigh circumference, passive knee ROM and maximum isometric knee extension power which will be measured at the beginning and end of each session and 1,3,7 days later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092429958N1
Registration date: 2016-11-24, 1395/09/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-24, 1395/09/04
Registrant information
Name
Armaghan Dabbagh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36350868
Email address
dabbagha@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-25, 1395/08/04
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effectiveness of a protocol involving whole-body vibration in individuals with delayed-onset muscle soreness after eccentric exercise
Public title
The effect of vibration on pain relief after exercise
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: male and female students of Shiraz University of Medical Sciences; aged 18-28; with no history of aerobic and weight training in the past 3 months at least Exclusion criteria: NSAIDS and similar treatments; the history of injuries to the knee; back and neck; the history of surgery in the past one year; having the contraindications for using the whole body vibration; such as: DM; seizure; metabolic and neurological diseases; osteoporosis; RA; prosthesis; irregular bleeding and orthopedic injuries.
Age
From 18 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences-
Street address
7th floor,Cenrtal department of Shiraz University of Medical Sciences, Zand BLVD, Shiraz, Iran
City
Shiraz
Postal code
71345-1978
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SUMS.REC.1395.83

Health conditions studied

1

Description of health condition studied
Delayed Onset Muscle Soreness
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
Pain
Timepoint
Immediately, 1,3,7 days later
Method of measurement
VAS, Algometery

Secondary outcomes

1

Description
Dominant thigh circumfrence
Timepoint
Immdiately, 1,3 and 7 days later
Method of measurement
Tape measure

2

Description
Passive knee range of motion
Timepoint
Immdiately, 1,3 and 7 days later
Method of measurement
Goniometery

3

Description
Maximum isometric knee extension
Timepoint
Immdiately, 1,3 and 7 days later
Method of measurement
Dynamometery

Intervention groups

1

Description
Intervention group: 1- 5 minutes warm up walking on treadmill at the speed of 3 km/h 2- 30 minutes walking on treadmill to introduce DOMS at the speed of 4 km/h and grade gradually raised to 10 3- 5 minutes cool down walking on treadmill at the speed of 3 km/h 4- treatment with WBV on the next day, participants stand on the plate while knees are bent 60 degrees (for maximum EMG activation of knee extensors) for one minute with the frequency of 30 Hz and Amplitude of 5 mm
Category
Treatment - Devices

2

Description
Control group: 1- 5 minutes warm up walking on treadmill at the speed of 3 km/h 2- 30 minutes walking on treadmill to introduce DOMS at the speed of 4 km/h and grade gradually raised to 10 3- 5 minutes cool down walking on treadmill at the speed of 3 km/h
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences, Rehabilitation School
Full name of responsible person
Armaghan Dabbagh
Street address
School of Rehabilitation Sciences, first Abiverdi St, Chamran BLVD
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyyed Basir Hashemi
Street address
7th floor,Cenrtal department of Shiraz University of Medical Sciences, Zand BLVD
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Armaghan Dabbagh
Position
MsC student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, 1st Abiverdi St, Chamran BLVD
City
Shiraz
Postal code
Phone
+7 136271551
Fax
Email
dabbagha@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Kamali
Position
Assiociate professor
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, 1st Abiverdi St, Chamran BLVD
City
Shiraz
Postal code
Phone
+98 716271552303
Fax
Email
fahimehkamali@hotmail.com
Web page address
www.rehab.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Aََrmaghan Dabbagh
Position
MsC student
Other areas of specialty/work
Street address
School of Rehabilitation Sciences, 1st Abiverdi St, Chamran BLVD
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
dabbagha@sums.ac.ir
Email
armaghan.dabbagh@gmail.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
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