Protocol summary

Study aim
Investigation of the effect of 8 weeks suspension training with TRX on sport-related injury predictor factor, performance and musculoskeletal pain in personnel of different branch of Navy of the Islamic Revolutionary Guard Corps
Design
Randomized trial with two arm parallel group, randomized assignment, on 50 subjects
Settings and conduct
The study will be conducted in one of the naval barracks of the Navy of the Islamic Revolutionary Guard Corps, and in coordination with the local authorities, with a full description of the purpose and how to implement the plan, according to the inclusion and exclusion criteria, 50 soldiers will enter the research plan.
Participants/Inclusion and exclusion criteria
Inclusion criteria: - Being in the desired age range -Membership in personnel of different branch of Navy of the Islamic Revolutionary Guard Corps - Exclusion criteria: the history of injury that makes movement restriction - the existence of any visible musculoskeletal deformities in the lower and upper extremity in normal standing posture - Failure to complete the training program for any reason - Absence of more than three practice sessions or two consecutive sessions - abnormal BMI, BMI<18 or BMI>28
Intervention groups
intervention group: TRx suspension training control group: Without receiving any intervention
Main outcome variables
Performance test, lower extremity injury risk factors predictors, musculoskeletal pain, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180821040843N2
Registration date: 2020-06-13, 1399/03/24
Registration timing: prospective

Last update: 2020-06-13, 1399/03/24
Update count: 0
Registration date
2020-06-13, 1399/03/24
Registrant information
Name
Esmaeil Mozafaripour
Name of organization / entity
The university of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1730
Email address
e.mozafaripour@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of suspension training with TRX on sport-related injury predictor factor, performance and musculoskeletal pain in personnel of different branch of Navy of the Islamic Revolutionary Guard Corps
Public title
The effect of 8 weeks of suspension training with TRX on sport-related injury predictor factor and performance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
membership in at least different branch of Navy of the Islamic Revolutionary Guard Corps Being in the desired age range
Exclusion criteria:
the existence of any visible musculoskeletal deformities in the lower and upper extremity in normal standing posture Not to participate in pre or post test losing more than three training sessions or two consecutive sessions abnormal BMI, BMI<18 or BMI>25
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign the subjects to the intervention and control groups, one number was considered for each subject. The numbers were randomly assigned to two groups using a random number table. To conceal numbers in each group, they were written on paper, and each one was kept in a numbered sealed, opaque envelope.
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 Baqiyatallah University of Medical Sciences
Street address
Vank square, Molla sadra st,Sheikh bahaei st Tehran, Islamic Republic of Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.BMSU.BAQ.REC.1398.016

Health conditions studied

1

Description of health condition studied
Musculoskeletal pain, musculoskeletal injuries
ICD-10 code
G89.2
ICD-10 code description
Chronic pain, not elsewhere classified

Primary outcomes

1

Description
Physical performance
Timepoint
In pre test before intervention and in post test after intervention
Method of measurement
Cooper’s 12-minute run, DEEP SQUAT JUMP, push-ups, sit-ups

Secondary outcomes

1

Description
injury risk factor predictors
Timepoint
In pre test before intervention and in post test after intervention
Method of measurement
Functional Movement Sneering test

2

Description
Musculoskeletal pain
Timepoint
In pre test before intervention and in post test after intervention
Method of measurement
Nordic pain questionnaires

Intervention groups

1

Description
Intervention group: ُSuspension Training with TRX: The intervention group will perform eight weeks of TRX Suspension Exercises as 3 sessions a week. This training protocol will be performed in the three phases (structural adaptation), the second phase (the main part of the exercise), and the third phase (maintenance phase).The design of the exercises in this protocol is such that in addition to focusing on improvement on the strength related factors of the different muscle groups, it will be implemented in circular methods in order to affect the cardiovascular system.
Category
Prevention

2

Description
Control group: without any intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University of Medical Sciences
Full name of responsible person
Esmaeil Mozafaripour
Street address
Vanak square, Molla Sadre st,Sheikh bahaei st, Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
e.mozafaripour@yahoo.com
Web page address
https://www.bmsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Hossein Shirvani
Street address
Vanak square, Molla sadre st, Sheikh Bahaei st, Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
shirvani.h2006@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
50
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Esmaeil Mozafaripour
Position
دانش آموخته مقطق دکتری رشته تربیت بدنی دانشگاه تهران
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No 51, Hoseinpor Ave, Paris Lomomba st, Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
e.mozafaripour@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Esmaeil Mozafaripour
Position
PHD graduated
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No. 51, Hoseinpor Ave, Patris Lomomba st, Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1445955985
Phone
+98 21 8804 0060
Email
e.mozafaripour@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Tehran
Full name of responsible person
Esmaeil Mozafaripou
Position
PhD graduated
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
No. 51, Hoseinpor Ave, Patris Lomomba st, Tehran, Islamic Republic
City
Tehran
Province
Tehran
Postal code
1445955985
Phone
+98 21 8804 0060
Email
e.mozafaripour@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
dependent variables value and how they will change in the post-test compared to the pre-test will be shared.
When the data will become available and for how long
Immediately after when the results published
To whom data/document is available
everyone
Under which criteria data/document could be used
Applicants declare their affiliations
From where data/document is obtainable
Esmaeil Mozafaripour Email: E.mozafaripour@yahoo.com Phone: 00989192787818
What processes are involved for a request to access data/document
The applicant can access the data by sending an email and a complete introduction of yourself.
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