Protocol summary

Study aim
To investigate the effect of Gluteus maximus muscle strengthening on some of the ACL injury risk factors
Design
Randomized control trial, parallel group design, not blinded, randomized
Settings and conduct
Sports lab of University of Isfahan, measurement of muscle strength by dynamometer, the intensity of muscle contraction by surface EMG, and biomechanical factors in landing test from a step on foot scan
Participants/Inclusion and exclusion criteria
18-30 year old non-athlete women with no lower extremity injury history in last 3 years and a full lower extremity range of motion
Intervention groups
Gluteus maximus muscle strengthening with Thera-band for 8 weeks 3 sessions for experimental group and no intervention for control group
Main outcome variables
The effect of Gmax muscle strengthening on reducing the intensity of Quadriceps muscle contraction to reduce the risk of ACL injury

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191020045165N1
Registration date: 2019-12-08, 1398/09/17
Registration timing: retrospective

Last update: 2019-12-08, 1398/09/17
Update count: 0
Registration date
2019-12-08, 1398/09/17
Registrant information
Name
Azadeh Doroodgar
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 3444
Email address
a.doroodgar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2019-11-16, 1398/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hip prime extensor strengthening on non-contact ACL injury risk factors; the intensity of Quadriceps femoris muscle contraction, lower extremity kinematics and ground reaction force
Public title
The effect of hip prime extensor strengthening on non-contact ACL injury risk factors
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women 18-30 years old
Exclusion criteria:
History of Lower extremity injury Lower extremity Pain and limited ROM Professional athlete (3-5 weekly training sessions)
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomized: A random number was assigned to each of the 30 volunteers. Then, one individual was randomly excluded from the container and assigned in the experimental and another one into control group.
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 University of Isfahan
Street address
No 106 Arjang dead-end Mehregan lane Nazar-e-sharghi st. Isfahan Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۳۷۶۳۹۱۵
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
IR.UI.REC.1398.048

Health conditions studied

1

Description of health condition studied
ACL injury
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee

Primary outcomes

1

Description
The intensity of Quadriceps muscle contraction
Timepoint
Initially and after 8 weeks of exercise
Method of measurement
Surface EMG

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Gluteus maximus muscle strengthening by thera-band 3 times per week for 8 weeks.
Category
Prevention

2

Description
Control group: no intervention
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Isfahan
Full name of responsible person
Khalil khayambashi
Street address
Sports sciences faculty,University of Isfahan, Hezarjerib st. Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2640
Email
A.doroodgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Rasool Roknizadeh
Street address
University of Isfahan Hezarjerib st.Isfahan Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2171
Email
Rokni@sci.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
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
University of Isfahan
Full name of responsible person
Khalil khayambashi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sports sciences faculty, University of Isfahan, Hezarjerib st., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+1 818-325-6399
Fax
Email
A.doroodgar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Khalil khayambashi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Sports sciences faculty, University of Isfahan, Hezarjerib st., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+1 818-325-6399
Fax
Email
Dr.khayam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Azadeh Doroodgar
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport injuries and corrective exercises
Street address
No.106 Arjang deadend Mehregan lane Nazar-e-sharghi street
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۳۷۶۷۵۱۱
Phone
+98 31 3629 3444
Fax
Email
A.doroodgar@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
Mean of anthropometric data and strength and the intensity of muscle contraction
When the data will become available and for how long
After publication
To whom data/document is available
Academics
Under which criteria data/document could be used
Research
From where data/document is obtainable
A.doroodgar@yahoo.com
What processes are involved for a request to access data/document
E-mail order, consideration up to 15 days,respond
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