Protocol summary

Study aim
This study investigated the effectiveness of two eight-week comprehensive corrective exercise programs in water and land on women with UCS
Design
Clinical trial with three intervention groups, with parallel groups, Double-blinded, randomized, phase 1 on 60 women with UCS
Settings and conduct
The exercise groups performed comprehensive corrective exercises under the supervision of a corrective exercise specialist in a corrective exercise clinic and swimming pool in Qouchan for eight weeks, three sessions per week, 30-60 minutes per session. In contrast, the control group received no treatment intervention for eight weeks. In the first session, subjects were asked to inform the instructor if they had any problems attending sessions on time so that a make-up session could be scheduled. Missing two consecutive sessions or a total of 3 sessions would result in the individual being dropped from the research program. This study was conducted in full compliance with research ethics principles, written informed consent was obtained from all participants, and their confidentiality was maintained.
Participants/Inclusion and exclusion criteria
In order to participate in the study, participants needed to have simultaneous postural abnormalities such as kyphosis, FH, and RS and express a willingness to participate. Those with signs of illness, fractures, surgeries, joint problems, injuries in the spine, skeletal-muscular imbalances, lower limb cross syndrome, abnormal BMI, or engaging in regular physical activity for at least 6 hours per week were not eligible to participate.
Intervention groups
land-based comprehensive corrective exercises (N=20), water-based comprehensive corrective exercises (N=20), and a control group (N=20)
Main outcome variables
Upper cross syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110803007211N2
Registration date: 2024-12-30, 1403/10/10
Registration timing: prospective

Last update: 2024-12-30, 1403/10/10
Update count: 0
Registration date
2024-12-30, 1403/10/10
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
05714413512
Email address
mseyedahmadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-09, 1403/10/20
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of 8 Weeks of Comprehensive Corrective Water and Land Exercises on Females with Upper Crossed Syndrome
Public title
Investigating the Impact of 8 Weeks of Comprehensive Corrective Water and Land Exercises on Females with Upper Crossed Syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants had to simultaneously have postural abnormalities such as kyphosis, Forward Head Posture, and Rounded Shoulders and express a willingness to participate.
Exclusion criteria:
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In the initial screening, 108 women with suspected signs of forward head, forward shoulder, and increased kyphosis postures will be identified through observation of posture using a checkerboard from the side view. The subjects' abnormalities (forward head angle, forward shoulder angle, and kyphosis angle) will then be evaluated using specialized tools and methods. Of these, 74 women who simultaneously have a forward head angle of more than 46 degrees, a forward shoulder angle of more than 52 degrees, and a kyphosis angle of more than 54 degrees will be considered to have UCS. A total of 60 women with UCS will be randomly selected and divided into three groups: land-based comprehensive corrective exercises (N=20), water-based comprehensive corrective exercises (N=20), and a control group (N=20).
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, evaluators, and analysts will be blinded to study group allocation, while researchers will be aware of the specific exercises each group will receive
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Human Ethics Research Committee of the Sport Sciences Research Institute of Iran
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2024-11-05, 1403/08/15
Ethics committee reference number
IR.SSRC.REC.1403.069

Health conditions studied

1

Description of health condition studied
Upper crossed syndrome (UCS)
ICD-10 code
M95.8
ICD-10 code description
Other acquired deformities of musculoskeletal system and connective tissue

Primary outcomes

1

Description
Upper crossed syndrome (UCS)
Timepoint
At the beginning of the study (before the start of the intervention) and at the end of the study (8 weeks after the intervention)
Method of measurement
Thoracic Kyphosis Angle: The Corrective Exercise Specialist will take measurements to assess the thoracic kyphosis angle. They will use a 50 cm long and 2 cm wide flexible ruler to measure the T2 and T12 vertebrae angle (24, 25). To find the T2 vertebra, the specialist will ask the participant to bend their head, identifying the spinous process of the T2 vertebra by first locating the C7 spinous process. They will mark the starting point of the kyphosis curve at the T2 vertebra and will use the Hoppenfeld method to determine the T12 vertebra (26). Individuals with a kyphotic angle greater than 46.83 degrees will be classified as having an increased kyphotic deformity. Rounded Shoulder Angle: The rounded shoulder angle (RSA) will be measured from the vertically posterior line to a line connecting the C7 and acromial markers (27). A shoulder angle of more than 52 degrees will be considered an RS deformity (22). Forward Head Angle: The forward head angle (FHA) will be measured from the vertical anterior to a line connecting the tragus and the C7 marker. In this method, an ideal head angle will be considered less than 36 degrees, while an angle of more than 46 degrees will be regarded as an abnormality (22) (Figure 2). The intraday reliability for FHA and RSA will show acceptable within-day reliability (FHA: Intraclass Correlation Coefficient (ICC)(2,1) = 0.92, Standard Error of the Mean (SEM) = 2; RSA ICC(2,1) = 0.89, SEM = 5) based on this sub-sample (28).

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: Land-based Comprehensive Corrective Exercise Program: The 8-week land-based comprehensive corrective exercise program will consist of 3 weekly sessions, each lasting 30-60 minutes. It will be performed under the supervision of a corrective exercise specialist in a corrective exercise clinic. Each session will include four types of combination exercises (strengthening, stretching, and mobility). Five minutes will be dedicated to warming up and cooling down before and after each session. The exercises will be designed based on the individual characteristics of each person. They will follow the principle of gradual overload, meaning that the number of repetitions and the duration of each movement will gradually increase over eight weeks. Specifically, the duration of holding the movements will increase from 5 to 15 seconds, and the number of repetitions per set will increase from 6 to 12. Additionally, the diameter of the foam rolls will increase from 15 cm to 20 cm and finally to 30 cm
Category
Rehabilitation

2

Description
Intervention group 2: Water-based comprehensive corrective exercises: The 8-week water-based corrective exercise protocol was designed based on the findings of Vladimir Janda's studies. These corrective exercises were performed in water for women with UCS under the supervision of a corrective exercise specialist. Based on previous research, the treatment of muscle imbalance was carried out in three stages in the pool(31). In the environmental normalization (inhibition) stage, trigger points were treated with water massage and myofascial release of tight muscles using foam rolling. In the muscle balance restoration stage, static stretches addressed muscle tightness and corrective breathing pattern exercises for the respiratory muscles (pectoralis major and scalenes) that become tight in UCS. Then, strengthening exercises were performed to address muscle weakness, as well as proprioceptive and motor exercises for the joints of the neck and shoulder area. The last stage of the exercise was the functional (integration) stage, in which individuals participated in a ball game in the water while maintaining correct posture. The exercise program was conducted for eight weeks and consisted of three sessions per week. Each session included 10-15 minutes of warm-up, 35-45 minutes of comprehensive corrective exercise, and 5-10 minutes of cool-down
Category
Rehabilitation

3

Description
Control group: Control group continued their usual daily activities. At the end of the intervention, measurements were repeated, and the data were analyzed.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Corrective Exercise clinic
Full name of responsible person
Karim Khalaghi
Street address
Motahari Street, Quchan
City
Qochan
Province
Razavi Khorasan
Postal code
9471787194
Phone
+98 51 4722 2011
Email
karim.khalaghi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Hakim Nizami Higher Education Institute in Quchan
Full name of responsible person
Dr .Nader Naqshbandi
Street address
Opposite Saipa Dealership, Quchan-Mashhad Sento Road
City
Qochan
Province
Razavi Khorasan
Postal code
9471787194
Phone
+98 51 4721 1773
Email
N.Naqshbandi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Educational and Research Affairs, Hakim Nizami Qochan Institute of Higher Education
Proportion provided by this source
100
Public or private sector
Private
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
Hakim Nizami Qochan Institute of Higher Education
Full name of responsible person
Karim Khalaghi
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Opposite Saipa Dealership, Quchan-Mashhad Sento Road
City
Qochan
Province
Razavi Khorasan
Postal code
9471787194
Phone
+98 51 4721 1773
Email
karim.khalaghi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Nizami Qochan Institute of Higher Education
Full name of responsible person
karim khalaghi
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Opposite Saipa Dealership, Quchan-Mashhad Sento Road
City
Qochan
Province
Razavi Khorasan
Postal code
9471787194
Phone
+98 51 4721 1773
Email
karim.khalaghi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Velayat University
Full name of responsible person
Mohammad Seyedahmadi
Position
Asistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Shahid Moradi Highway, Iranshahr, Sistan and Baluchistan
City
iranshhr
Province
Sistan-va-Balouchestan
Postal code
9911131311
Phone
0543721252
Email
mseyedahmadi@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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data files will be available to researchers after the publication of the abstracted article
When the data will become available and for how long
After publication the article
To whom data/document is available
Other researchers
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
All researchers
What processes are involved for a request to access data/document
Upon receiving a formal request for data or documentation, the process will involve review and approval by the corresponding author. Once the request is approved, the required data and documents will be prepared and provided to the requester within one week. This process includes thoroughly reviewing the request, preparing the data, and ensuring that the information provided aligns with the original request.
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