Protocol summary

Study aim
This study aimed to investigate the effect of 12-week corrective exercises on the forward head, forward shoulder and kyphosis angles in females with Upper crossed syndrome
Design
Randomized control trial with control group, with parallel groups, without blindness
Settings and conduct
Forty women with Upper crossed syndrome will recruit and randomly assign in two control and experimental groups. All measurements will perform in biomechanics laboratory of faculty of physical education at Allame Tabataba'i University.
Participants/Inclusion and exclusion criteria
The inclusionary criteria are female gender, forward shoulder angle more than 52°, forward head angle more than 46°, and kyphosis angle more than 42°. The exclusionary criteria are history of cervical or thoracic spine surgery, observing significant scoliosis, torticollis, and cervical spine instability based on the New York Postural Assessment Tool. Besides, the participants were excluded if they were involved in other training programs and did not participate in training sessions regularly for last 1 years.
Intervention groups
A corrective exercise program will be implemented for 12 weeks. Each training session will beginning with ten minutes warm-up and ended with ten minutes cool-down. The self-myofascial release technique will execute in the first phase of the corrective exercise continuum to inhibit and release latissimus dorsi, upper trapezius, sternocleidomastoid, levator scapula muscles, and thoracic spine. Stretching exercises will prescribe for these muscles, too. Isolated strengthening exercises including quadruped ball chin tucks, resisted cervical posterior translation, floor prone scaption, and ball combo I. In the last phase, integrated dynamic movements will perform.
Main outcome variables
forward shoulder angleو forward head angle, and kyphosis angle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180626040244N2
Registration date: 2021-04-18, 1400/01/29
Registration timing: prospective

Last update: 2021-04-18, 1400/01/29
Update count: 0
Registration date
2021-04-18, 1400/01/29
Registrant information
Name
Rahman Sheikhhoseini
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 4839 4134
Email address
rahmanhoseini@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-30, 1400/02/10
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12-week corrective exercises on the upper quarter posture in females with upper crossed syndrome
Public title
The effect of corrective exercises on upper crossed syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
forward shoulder angle more than 52 degrees forward head angle more than 46 degrees kyphosis angle more than 42 degrees Age between 25-40 years old
Exclusion criteria:
significant scoliosis in the spine presence of torticollis history of thoracic spine surgery history of cervical spine surgery
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done as simple method with card. The type of intervention will be put in sealed envelopes. Individuals are listed in order of attendance. After including in the study, the envelops will shuffled and each person is asked to select an envelope. The subjects will be asked to select one envelope. According to the predicted sample size, the number of envelope will be provided. Therefore, any selected envelope will not return to randomization sequence. This type of randomization can result to have the same number of individuals in both groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Not available

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University, Tehran Science and Research Branch
Street address
Hesarak Shohada Bulevered
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2021-02-14, 1399/11/26
Ethics committee reference number
IR.IAU.SRB.REC.1399.167

Health conditions studied

1

Description of health condition studied
Upper crossed syndrome
ICD-10 code
R29.3
ICD-10 code description
Abnormal posture

Primary outcomes

1

Description
Forward head angle more than 46°
Timepoint
Before starting the study and after 12 weeks of prescribing corrective exercises
Method of measurement
The photogrammetric method by calculating angles from a captured pictures

Secondary outcomes

1

Description
Forward shoulder angle more than 52 degrees
Timepoint
At study start and end of 12 weeks of corrective exercises
Method of measurement
The photogrammetric method by calculating angles from a captured pictures

2

Description
Kyphosis angle more than 42°
Timepoint
At study start and end of 12 weeks of corrective exercises
Method of measurement
With flexible ruler with 70 centimeters of length

Intervention groups

1

Description
Intervention group: 12 weeks of corrective exercises, 3 sessions per week, 45 minutes for each session. Number (adding one set) and time (adding 5 seconds) of doing sets increase progressively each weak. to prevent from fatigue, allocated 30 seconds rest between each set
Category
Prevention

2

Description
Control group: No intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahmanhoseini@atu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Hashem Piri
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8630
Email
hpiry63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
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
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahman.pt82@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahman.pt82@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Rahman Sheikhhoseini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chogan street
City
Tehran
Province
Tehran
Postal code
1485743411
Phone
+98 21 4411 8629
Email
rahman.pt82@gmail.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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All primary and secondary data will be share in the future after making them unidentifiable
When the data will become available and for how long
Data will be available immediately after publishing the study results
To whom data/document is available
All academic people and researchers
Under which criteria data/document could be used
Data will be share for systematic review and meta-analyses studies, or for any researchers who need for our data for research proposes
From where data/document is obtainable
Data request can be sent to following Emails: 1. rahman.pt82@gmail.com, 2. hpiry63@gmail.com, and 3. rahmanhoseini@atu.ac.ir
What processes are involved for a request to access data/document
All requests will be answered immediately after receiving Emails, for maximum of 1 week
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