Protocol summary

Study aim
Comparison of the effects of two postural habit retraining approaches and selected corrective exercises on pain and complications of upper cruciate syndrome in middle-aged men.
Design
A randomized clinical trial study, single-blind, Factorial, 30 randomized to two intervention groups and a control group
Settings and conduct
Participants are divided into two groups of intervention and control groups. This study was single-blind and the outcome assessor is blind to interventions. This study will be conducted in the faculty of physical education at Kharazmi university. The protocols are 8 weeks and three 40-minute sessions per week.
Participants/Inclusion and exclusion criteria
Having a head-forward deformity greater than 46 degrees, Round shoulder greater than 52 degrees, Kyphosis greater than 42 degrees, Men with an age range of 30-59 years
Intervention groups
Intervention group 1: Corrective exercise protocol - Exercises were performed for six weeks and three sessions per week for the exercise group. The duration of each training session was 40 minutes, consisting of 5 minutes of warming up and 5 minutes of cooling down. the exercises include 3 levels: beginner, intermediate, and advanced. The exercises are aimed at strengthening and stretching the muscles of the upper limbs and the supporting muscles of the neck. Intervention group 2: Exercises to retrain postural habits These exercises include teaching ergonomic considerations and postural habits of a person during daily life in activities such as standing, walking, sitting, sleeping, reading, using a computer, and other activities that were performed repeatedly and continuously during the day. These subjects were taught three times a week for 40 minutes. Control group: without any intervention. During this period
Main outcome variables
Visual Analogue Scale, Forward Head, kyphosis, rounded shoulders

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180627040251N7
Registration date: 2024-06-05, 1403/03/16
Registration timing: prospective

Last update: 2024-06-05, 1403/03/16
Update count: 0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Hassan Sadeghi
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
hassan.sadeghi81@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2024-08-05, 1403/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two approaches of reposture training and selected corrective exercises on pain and complications of upper cross syndrome in middle-aged men
Public title
Comparison of the effect of two approaches of reposture training and selected corrective exercises on pain and complications of upper cross syndrome in middle aged men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a head-forward deformity greater than 46 degrees Round shoulder greater than 52 degrees Kyphosis greater than 42 degrees Men with an age range of 30-59 years
Exclusion criteria:
Pathological symptoms related to the history of fracture, surgery or articular diseases of the spine Who participated in regular exercise programs in the last 6th month Acute vision and hearing problems
Age
From 30 years old to 59 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After the initial evaluation, randomization was done using randomization blocks of 4 methods. Patients are randomly assigned to one of two groups through four random blocks. A member of the research team who is not involved in the selection of samples will determine the randomization sequence using an online randomization system (randomizer.org). Participants will be notified of their group allocation with a sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favour of a specific therapeutic intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Kharazmi University-Iran
Street address
Enghlab- Mofateh St. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۹۱۱-۱۵۷۱۹
Approval date
2024-05-05, 1403/02/16
Ethics committee reference number
IR.KHU.REC.1403.026

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain

2

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

Primary outcomes

1

Description
Visual Analogue Scale
Timepoint
before intervention; immediately after intervention
Method of measurement
Score of 100 mm visual analog scale to assess pain intensity

Secondary outcomes

1

Description
Forward Head
Timepoint
before intervention; immediately after intervention
Method of measurement
Measure of Cervicovertebral angle with Goniometer

2

Description
kyphosis
Timepoint
before intervention; immediately after intervention
Method of measurement
The measure of angle betweenC7 and T12 by kyphometer

3

Description
rounded shoulders
Timepoint
before intervention; immediately after intervention
Method of measurement
Measure of Acromion angle and floor with goniometer

Intervention groups

1

Description
Intervention group 1: Corrective exercise protocol - Exercises were performed for six weeks and three sessions per week for the exercise group. The duration of each training session was 40 minutes, consisting of 5 minutes of warming up and 5 minutes of cooling down. the exercises include 3 levels: beginner, intermediate and advanced. All exercises are under the supervision of a physiotherapist. The exercises are aimed at strengthening and stretching the muscles of the upper limbs and the supporting muscles of the neck
Category
Rehabilitation

2

Description
Intervention group 2: Exercises to retrain postural habits These exercises include things that a person should remember and consider on a daily basis. These include teaching ergonomic considerations and postural habits of a person during daily life in activities such as standing, walking, sitting, sleeping, reading, using a computer, and other activities that were performed repeatedly and continuously during the day. These subjects were taught three times a week for 40 minutes
Category
Rehabilitation

3

Description
Control group: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sport Sciences. Kharazmi University
Full name of responsible person
Azam Ahmadi
Street address
Faculty of Physical Education and Sports Sciences, Kharazmi University,, University Square, at the end of Shahid Beheshti St. Karaj
City
karaj
Province
Tehran
Postal code
3755131979
Phone
+98 26 3451 2001
Email
labrotary.pess.khu@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Mohammad Delnavaz
Street address
Vice-Chancellor for Research and Technology. No. 43. South Mofatteh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Fax
Email
Delnavaz@khu.ac.ir
Web page address
https://research.khu.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi 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
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Fax
Email
hassan.sadeghi81@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Fax
Email
hassan.sadeghi81@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Fax
Email
hassan.sadeghi81@yahoo.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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