Protocol summary

Summary
Objective: Determining the effects of core stability trainings on movement dysfunctions and balance situation among working women. Design: This study is a Clinical trial (second phase).Participants receive the same intervention, before and 12 weeks after the intervention but with no control group. The study population is defined as female workers working in Imam Khomeini Hospital complex, Tehran University of Medical Sciences. Sample size included 50 women. In this single-center study, there is no need to blinding and randomization. Setting and conduct: participants will perform screening test, Y Balance test, and modified t test before starting clinical interventions. Then each of the study samples will receive appropriate training program, based on her physical condition. After performing the training program, screening test, Y Balance test, and modified t test will be re-evaluated. The main criteria for inclusion: In this study being a female worker between 30- 50 years old considered as inclusion criteria. Exclusion criteria: A history of injuries or surgeries on the trunk and lower extremities in the past year Intervention or interventions: Performing core stability trainings (including: agility, balance) for 12 weeks. The duration of clinical interventions: 12 weeks. Primary studied outcome or outcomes: The frequency of movement dysfunctions, evaluating balance and agility before and 12 weeks after performing core stability trainings.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016090619054N2
Registration date: 2016-10-10, 1395/07/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Seyedeh Shohreh Alavi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21889985
Email address
alavi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice- chancellor for research,Tehran University of Medical Sciences.
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Movement dysfunctions among female employees and effects of core stability trainings on their motor function and balance.
Public title
Movement dysfunctions
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women aged between 30 to 50 years Exclusion criteria: a history of injuries or surgeries on the trunk and lower extremities in the past year
Age
From 30 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
The central building of Tehran University of Medical Sciences , Qods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-09-03, 1395/06/13
Ethics committee reference number
IR.TUMS.VCR.REC.1395.538

Health conditions studied

1

Description of health condition studied
Mosuloskeletal disorders
ICD-10 code
-
ICD-10 code description
-

Primary outcomes

1

Description
Movement dysfunctions
Timepoint
Pre intervention and 12 weeks after it
Method of measurement
Functional movement Screening test

Secondary outcomes

1

Description
Agility
Timepoint
Pre intervention and 12 weeks after it
Method of measurement
Modified t test

2

Description
Balance
Timepoint
Pre intervention and 12 weeks after it
Method of measurement
Y Balance test

Intervention groups

1

Description
This study is an interventional study with no control group.The interventions for all participants included exercise training programs (core stability trainings). Modified t test, Y balance test and functional movement screening test are utilized to identify movement dysfunctions.Participants' training programs varies based on their Physical conditions. Samples perform their exercises 3 times a week during 12 weeks. Each session lasts approximately one hour.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital Complex
Full name of responsible person
Dr. Seyedeh Shohreh Alavi
Street address
1,Enayat Alley, Pursina Ave,16 Azar St,Keshavarz Blvd, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice- chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
vice- chancellor for research of Tehran University of Medical Sciences, 6th floor, Qods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
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 Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fariba Akbari
Position
Research expert/Bachelor
Other areas of specialty/work
Street address
The central building of Tehran University of Medical Sciences, Qods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8163 3615
Fax
+98 21 8899 4485
Email
alavi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Shohreh Alavi
Position
Researcher /PhD in Distance Education planning
Other areas of specialty/work
Street address
1,Enayat Alley, Pursina Ave,16 Azar St,Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8899 4487
Fax
+98 21 8899 4485
Email
alavi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Shohreh Alavi
Position
Researcher /PhD in Distance Education planning
Other areas of specialty/work
Street address
1,Enayat Alley, Pursina Ave,16 Azar St,Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Phone
+98 92188994486
Fax
+98 21 8899 4485
Email
alavi@tums.ac.ir
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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