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Effect of eight weeks of hopping and combined (balance- strength) training on balance, strength and function of lower limbs of soccer men with chronic ankle instability.

Protocol summary

Study aim
The effect of hopping and combined (balance - strength) trainings on balance, lower extremities strength and function in soccer men suffering chronic ankle instability.
Design
Clinical trial with control group, with parallel groups, without blinding, randomized.
Settings and conduct
The study was conducted at Kharazmi University, Subjects were selected and randomly divided into three groups of twelve (Hopping training: 12, Balance - Strength:12, Control:12).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men soccer players suffering chronic ankle instability , the age of 18 to 25 years, The subject should not undergo any other treatment at the time of this study. Exclusion criteria: History of surgery in the trunk and lower extremity, Acute sprain symptoms in the ankle for the past six months.
Intervention groups
Intervention group1:Hopping training consisting of 6 types of hopping training that were progressively intensified by adding weekly training were performed for 8 weeks, 3 times a week, and each session for 30 minutes. Intervention group 2: Combined training (balance - strength) consisted of 13 types of training that were performed for 8 weeks (3 session per week and 30 minute each session). the protocol included training such as plank bridge, working out with a resistance band and working with wobble board, also increasing the intensity of the set with increasing number of sets and repetitions, and increased the intensity of the training every two weeks. Control group: control group performed their daily activities for 8 weeks.
Main outcome variables
Balance, strength, function of lower extremities

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190830044643N1
Registration date: 2019-12-21, 1398/09/30
Registration timing: retrospective

Last update: 2019-12-21, 1398/09/30
Update count: 0
Registration date
2019-12-21, 1398/09/30
Registrant information
Name
hadi mohammadi nia samakosh
Name of organization / entity
The University of kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 11 3272 3604
Email address
std_shahramsamakosh92@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-15, 1397/03/25
Actual recruitment start date
2018-04-09, 1397/01/20
Actual recruitment end date
2018-06-17, 1397/03/27
Trial completion date
2018-06-17, 1397/03/27
Scientific title
Effect of eight weeks of hopping and combined (balance- strength) training on balance, strength and function of lower limbs of soccer men with chronic ankle instability.
Public title
Effect of training program on balance, strength and function of soccer players with chronic ankle instability.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Men soccer players suffering chronic ankle instability. The age range of 18 to 25 years. The subject should not undergo any other treatment at the time of this study.
Exclusion criteria:
History of surgery in the trunk and lower extremity. Acute sprain symptoms in the ankle for the past six months.
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects were randomized based on Random Number Generator software and then they were assigned to Hopping, combined (Balance - Strength), and control groups based on allocation concealment by SNOSE (Sequentially numbered, sealed, opaque envelopes) method.
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 Tarbiat Modarres University
Street address
Bridge Nasr, Jalal Al Ahmad, Tehran
City
Tehran
Province
Tehran
Postal code
33111-15477
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.MODARES.REC.1397.043

Health conditions studied

1

Description of health condition studied
Ankle chronic sprain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Balance
Timepoint
Before and one week after intervention.
Method of measurement
Static with Bass Stick, Dynamic from Y test.

2

Description
Strength
Timepoint
Before and one week after intervention.
Method of measurement
Manual Muscle Test (North coast) mading from United States

3

Description
Function of the lower extremities
Timepoint
Before and one week after intervention.
Method of measurement
High Jump test and Hopping tests.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Hopping training were performed for 8 weeks consisting of six types of hop (hop forward, backward, side, zigzag, etc.), that were progressively intensified by adding weekly training, three times a week and each session lasted for 30 minutes.
Category
Prevention

2

Description
Intervention group2: Combined training (balance - strength) consisted of 13 types of training that were performed for 8 weeks (3 session per week and 30 minute each session). the protocol included training such as plank bridge, working out with a resistance band and working with wobble board, The intensity of training also increased with increasing number of sets and repetitions and every two weeks the intensity of training increased.
Category
Prevention

3

Description
Control group: control group performed their daily activities.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The University of kharazmi
Full name of responsible person
Hadi Mohammadi Nia Samakosh
Street address
School of Physical Education and Sport Sciences, Shahid Keshvari Complex, End of Mirdamad - End of South Razan Street, Tehran
City
Tehran
Province
Tehran
Postal code
33111-15477
Phone
+98 21 2222 8001
Fax
+98 21 2226 9547
Email
std_shahramsamakosh92@khu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of the University of Kharazmi
Full name of responsible person
Ahamd Zanganeh
Street address
No.43. South Mofatteh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8883 0893
Fax
+98 21 8607 0905
Email
zanganeh@yahoo.com
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 of the University of Kharazmi
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
The University of kharazmi
Full name of responsible person
Hadi Mohammadi Nia Samakosh
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Sport Injury and Corrective Exercise
Street address
School of Physical Education and Sport Sciences, Shahid Keshvari Complex, End of Mirdamad - End of South Razan Street, Tehran
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 8882 5818
Email
std_shahramsamakosh92@khu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of kharazmi
Full name of responsible person
Hadi Mohammadi Nia Samakosh
Position
Master of Science
Latest degree
Master
Other areas of specialty/work
Sport Injury and Corrective Exercise
Street address
School of Physical Education and Sport Sciences, Shahid Keshvari Complex, End of Mirdamad - End of South Razan Street, Tehran
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Email
std_shahramsamakosh92@khu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Kharazmi
Full name of responsible person
Hadi Mohammadi Nia Samakosh
Position
Master of Scinece
Latest degree
Master
Other areas of specialty/work
Sport Injury and Corrective Exercise
Street address
School of Physical Education and Sport Sciences, Shahid Keshvari Complex, End of Mirdamad - End of South Razan Street, Tehran
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2248 6439
Email
std_shahramsamakosh92@kho.ac.ir

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
Not applicable
Title and more details about the data/document
Only part of the data such as information about the original outcome or the our like can be shared.
When the data will become available and for how long
Beginning access from 2020.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
For scientific and research use and mention of research title and researcher name.
From where data/document is obtainable
Request from researcher email: std_shahramsamakosh92@khu.ac.ir
What processes are involved for a request to access data/document
Request from researcher email: std_shahramsamakosh92@khu.ac.ir
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