History
# Registration date Revision Id
2 2020-10-04, 1399/07/13 153547
1 2020-09-06, 1399/06/16 149735
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  • General information

    2020-08-20, 1399/05/30
    2020-12-20, 1399/09/30
    empty
    changing the expected date of recruitment.
    empty
    تغییر تاریخ شروع بیمارگیری مورد انتظار
  • Recruitment centers

    #1
    Name of recruitment center - English: The University of Shahid Beheshti Tehran, IRAN
    Name of recruitment center - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Zohreh Yaghoubi Tajani
    Full name of responsible person - Persian: زهره یعقوبی تاجانی
    Street address - English: 4th Floor, No. 1, Niayesh Blind Alley, Soheili Blind Alley, Bahar st., Kabiri Tame Blvd. , West Abshenasan
    Street address - Persian: آبشناسان غرب - بلوار شهید کبیری طامه - خیابان بهار - بن بست شهید سهیلی - بن بست نیایش - پلاک ۱ - طبقه ۴
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1475893461
    Phone: +98 21 4443 5988
    Fax:
    Email: zohreh.yaghoubi@gmail.com
    Web page address:
    Name of recruitment center - English: The University of Shahid Beheshti Tehran, IRAN
    Name of recruitment center - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Sajjad Ahmadizad
    Full name of responsible person - Persian: سجاد احمدی زاد
    Street address - English: Daneshjoo Blvd., Shahid Shahriari Square, Yemen St., Shahid Chamran Highway
    Street address - Persian: بزرگراه شهید چمران، خیابان یمن،ميدان شهيد شهرياری، بلوار دانشجو
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 2990 5824
    Fax:
    Email: sahmadizad@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: The University of Shahid Beheshti
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Zohreh Yaghoubi Tajani
    Full name of responsible person - Persian: زهره یعقوبی تاجانی
    Street address - English: 4th Floor, No. 1, Niayesh Blind Alley, Soheili Blind Alley, Bahar st., Kabiri Tame Blvd. , West Abshenasan
    Street address - Persian: آبشناسان غرب - بلوار شهید کبیری طامه - خیابان بهار - بن بست شهید سهیلی - بن بست نیایش - پلاک ۱ - طبقه ۴
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1475893461
    Phone: +98 21 4443 5988
    Fax:
    Email: zohreh.yaghoubi@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: The University of Shahid Beheshti
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Babak Shokri
    Full name of responsible person - Persian: بابک شکری
    Street address - English: Daneshjoo Blvd., Shahid Shahriari Square, Yemen St., Shahid Chamran Highway
    Street address - Persian: بزرگراه شهید چمران، خیابان یمن،ميدان شهيد شهرياری، بلوار دانشجو
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 2990 2788
    Fax:
    Email: b-shokri@sbu.ac.ir
    Web page address:

Protocol summary

Study aim
The purpose of this study is to evaluate the effectiveness of supervised-based versus workplace-based exercises on neck-shoulder pain, workability, alignment, and muscle activity among office workers with upper crossed syndrome.
Design
A quasi-experimental; randomized controlled clinical trial including 45 samples assigned randomly to two groups: supervised exercises; workplace exercises, and a control group.
Settings and conduct
The participants with upper crossed syndrome in two groups supervised exercises and workplace exercises performing 50 minutes of intervention 3 sessions per week for eight weeks; the control group receives no intervention. Baseline assessments will be organized at the physical education laboratory at the University of Shahid Beheshti in Tehran- Iran which, will be repeated after eight weeks of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: office workers in Tehran between the age of 25 to 50 years being at work for more than five years and 30 hours per week with postural alteration including the forward head equal to or more than 45°; round shoulder equal to or more than 52°; and round back equal to or more than 42° as well as neck and shoulder pain intensity equal to or more than three as per visual analog scale. Exclusion criteria: body mass index (BMI) equal to or more than 25 or equal to or less than 18; being pregnant; having a previous upper-body injury or not being able to take exercises due to any medical conditions.
Intervention groups
Intervention 1: workplace exercises: 50-minute exercise, 3 days per week with 3 repetitions, holding for10 seconds for 8 weeks. Intervention 2: supervised exercises: 50-minute exercise, three days per week with three repetitions, holding for10 seconds for 8 weeks. 3: control group: receive no intervention.
Main outcome variables
Neck-shoulder pain; workability; alignment; muscle activity

General information

Reason for update
changing the expected date of recruitment.
Acronym
IRCT registration information
IRCT registration number: IRCT20200729048249N1
Registration date: 2020-09-06, 1399/06/16
Registration timing: prospective

Last update: 2020-10-05, 1399/07/14
Update count: 1
Registration date
2020-09-06, 1399/06/16
Registrant information
Name
ZOHREH YAGHOUBI TAJANI
Name of organization / entity
The University of Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 21 4443 5988
Email address
zohreh.yaghoubi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of supervised versus work-placed exercises on neck-shoulder pain, workability, alignment and muscle activities among office workers with upper crossed syndrome
Public title
Effectiveness of exercise on upper crossed syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Office workers being at work for more than five years and 30 hours per week Forward head posture equal to or more than 45°, round shoulder equal to or more than 52°, and round back equal to or more than 42° Pain intensity equal to or more than three in the neck and shoulder as per visual analog scale
Exclusion criteria:
Pregnancy Previous upper-body injuiry Not being able to do exercise due to any medical conditions Bodyweight out of the normal range; having body mass index (BMI) equal to or more than 25 or equal to or less than 18
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The website https://www.sealedenvelope.com will be applied to randomize and generate a random block sequence, and sealed opaque envelopes will be used to conceal random allocation. Based on the sample size, a number of envelopes with aluminum wrappers are used in order to obscure the contents of the envelopes. Each of the random sequences is written on a card, and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered on the outer surface as well. The envelopes are glued and placed inside a box, respectively. The participants open one of the envelopes, then the assigned group of that participant is revealed.
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
Research Ethics Committee in Shahid Beheshti University Tehran, IRAN
Street address
Daneshjoo Blvd., Shahid Shahriari Square, Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.SBU.REC.1399.036

Health conditions studied

1

Description of health condition studied
Upper Crossed Syndrome
ICD-10 code
M40.04
ICD-10 code description
Postural Kyphosis, Thoracic Region

Primary outcomes

1

Description
Neck–shoulder pain
Timepoint
Before and after eight weeks of intervension
Method of measurement
Visual analogue scale (VAS)

Secondary outcomes

1

Description
Work ability
Timepoint
Before and after eight weeks of intervension
Method of measurement
Work ability index (WAI) questionnaire

2

Description
Alignment
Timepoint
Before and after eight weeks of intervension
Method of measurement
Photogrammetry

3

Description
Muscles activity
Timepoint
Before and after eight weeks of intervension
Method of measurement
Surface electromyography

Intervention groups

1

Description
Intervention group 1( work-placed exercises): An eight-week exercise program including corrective exercises based on alignment and effective muscle activation on upper crossed syndrome will be taken three days per week about 50 minutes each session which will be started by five to seven minutes of warm-up and cool-down. The exercises will be initiated by three repetitions holding for 10 seconds, and progress to six repetitions, holding for 25 seconds based on the overload principles and the individual capabilities. The present study aims to evaluate the effectiveness of exercises in the workplace that will be performed without the direct supervision of the researcher as the first intervention group.
Category
Prevention

2

Description
Intervention group2( supervised exercises): An eight-week exercise program including corrective exercises based on alignment and effective muscle activation on upper crossed syndrome will be taken three days per week about 50 minutes each session which will be started by five to seven minutes of warm-up and cool-down. The exercises will be initiated by three repetitions holding for 10 seconds, and progress to six repetitions, holding for 25 seconds based on the overload principles and the individual capabilities. The present study aims to evaluate the effectiveness of supervised exercises as the second intervention group that will be performed under direct supervision.
Category
Prevention

3

Description
Control group: receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The University of Shahid Beheshti Tehran, IRAN
Full name of responsible person
Sajjad Ahmadizad
Street address
Daneshjoo Blvd., Shahid Shahriari Square, Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5824
Email
sahmadizad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Babak Shokri
Street address
Daneshjoo Blvd., Shahid Shahriari Square, Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2788
Email
b-shokri@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The University of Shahid Beheshti
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 Shahid Beheshti
Full name of responsible person
Zohreh Yaghoubi Tajani
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises
Street address
4th Floor, No. 1, Niayesh Blind Alley, Soheili Blind Alley, Bahar st., Kabiri Tame Blvd. , West Abshenasan
City
Tehran
Province
Tehran
Postal code
1475893461
Phone
+98 21 4443 5988
Email
zohreh.yaghoubi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The Universiy of Shahid Beheshti
Full name of responsible person
Zohreh Yaghoubi Tajani
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises
Street address
4th Floor, No. 1, Niayesh Blind Alley, Soheili Blind Alley, Bahar st., Kabiri Tame Blvd. , West Abshenasan
City
Tehran
Province
Tehran
Postal code
1475893461
Phone
+98 21 4443 5988
Email
zohreh.yaghoubi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Zohreh Yaghoubi Tajani
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises
Street address
4th Floor, No. 1, Niayesh Blind Alley, Soheili Blind Alley, Bahar st., Kabiri Tame Blvd, West Abshenasan
City
Tehran
Province
Tehran
Postal code
1475893461
Phone
+98 21 4443 5988
Email
zohreh.yaghoubi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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