Protocol summary

Study aim
To determine the effect of eight weeks of local and comprehensive injury prevention exercises on sports performance, upper limb stability and function, and rotator cuff muscle endurance in adolescent swimmers
Design
A clinical trial with three parallel groups, double-blind, randomized, with a sample size of 26 participants and phase 3. Randomization was performed using the RAND function in Microsoft Excel.
Settings and conduct
This was a randomized parallel clinical trial on healthy adolescent swimmers at Tadbir and Omid Swimming Pool, Ilam. The study evaluated the effect of injury prevention exercises on shoulder function and endurance. Participants provided consent and were assigned to three groups: control, local, and comprehensive, with interventions lasting eight weeks, three sessions per week. Outcome assessors and data analysts were blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Male gender; Adolescent swimmers aged between 10 and 17 years; Non-professional (amateur) participants; Completion and signing of written informed consent form Exclusion Criteria: Presence of any disease or history of injury; History of surgery in the shoulder girdle region
Intervention groups
Control group: Performed routine weekly swimming Local exercises group: Performed stretching, activation, and strengthening exercises for the shoulder muscles Comprehensive exercises group: Performed shoulder stretching, activation, and strengthening exercises, in addition to scapular stabilizer exercises, core muscle exercises, and integrated neuromuscular training
Main outcome variables
Upper limb stability in the closed kinetic chain; Upper limb dynamic stability; Rotator cuff muscle endurance; Front crawl performance of adolescent swimmers

General information

Reason for update
Acronym
IPES
IRCT registration information
IRCT registration number: IRCT20180521039762N3
Registration date: 2025-10-28, 1404/08/06
Registration timing: retrospective

Last update: 2025-10-28, 1404/08/06
Update count: 0
Registration date
2025-10-28, 1404/08/06
Registrant information
Name
Afshin Moghadasi
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 4208
Email address
afshin.moghadasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-11, 1404/01/22
Expected recruitment end date
2025-04-16, 1404/01/27
Actual recruitment start date
2025-04-11, 1404/01/22
Actual recruitment end date
2025-04-14, 1404/01/25
Trial completion date
2025-06-19, 1404/03/29
Scientific title
Effect of Localized and Comprehensive Injury Prevention Exercises on Performance, Stability, Upper Limb Function, and Rotator Cuff Muscle Endurance in Adolescent Swimmers
Public title
Effect of Injury Prevention Exercises on Shoulder Muscle Endurance and Performance in Adolescent Swimmers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender Adolescent swimmers aged between 10 and 17 years Amateur participants Completion and signing of written informed consent form
Exclusion criteria:
Having any disease or injury History of surgery in the shoulder girdle region
Age
From 10 years old to 17 years old
Gender
Male
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 26
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple individual randomization was used. The random sequence was generated using Microsoft Excel with the RAND function. Each participant was randomly assigned to one of three study groups (control, local exercises, comprehensive exercises). For allocation concealment, sealed opaque envelopes were used to ensure that both participants and assessors were unaware of the assigned group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, outcome assessors and data analysts were blinded to group assignments to prevent bias in data collection and analysis. Participants were aware of their assigned group because they needed to receive full information about the intervention. The principal investigator and personnel responsible for administering the exercises were also aware of group assignments. The Data Safety and Monitoring Committee was not involved in this study.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Payame Noor University
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
19395-4697
Approval date
2024-11-16, 1403/08/26
Ethics committee reference number
IR.PNU.REC.1403.406

Health conditions studied

1

Description of health condition studied
Shoulder injuries in adolescent swimmers
ICD-10 code
M75
ICD-10 code description
Shoulder lesions

Primary outcomes

1

Description
Upper limb stability in the closed kinetic chain; Measured using the Davis test, indicating the ability to control upper limb movements in stable positions
Timepoint
Before the intervention and after the completion of the 8-week exercise intervention
Method of measurement
Measured using the Davis test

2

Description
Upper limb dynamic stability; Measured using the Y Balance Test, indicating control and coordination of hand and arm movements in multiple directions
Timepoint
Before the intervention and after the completion of the 8-week exercise intervention
Method of measurement
Measured using the Y Balance Test

3

Description
Rotator cuff muscle endurance; Measured using the repetitive external shoulder rotation test with dumbbells, indicating the ability of muscles to perform repeated activity
Timepoint
Before the intervention and after the completion of the 8-week exercise intervention
Method of measurement
Measured using the repetitive external shoulder rotation test with dumbbells

4

Description
Front crawl performance; Measured using the 50-meter front crawl time, number of strokes, and stroke-to-time ratio, indicating overall swimming performance
Timepoint
Before the intervention and after the completion of the 8-week exercise intervention
Method of measurement
Measured using 50-meter front crawl time, number of strokes, and stroke-to-time ratio

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1 (Local Exercise Group): Participants performed stretching, activation, and strengthening exercises for the shoulder muscles. Each session lasted between 30 to 75 minutes and was conducted three times per week for 8 weeks.
Category
Prevention

2

Description
Intervention Group 2 (Comprehensive Exercise Group): In addition to stretching, activation, and strengthening exercises for the shoulder muscles, participants performed exercises for the scapular stabilizing muscles, core muscles, and integrated neuromuscular training. Each session lasted the same duration as Intervention Group 1, and the program was conducted three times per week for 8 weeks.
Category
Prevention

3

Description
Control group: Participants only followed their regular weekly swimming routine and did not receive any additional exercise intervention.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tadbir and Omid Sports Complex Swimming Pool
Full name of responsible person
Yaghoob Baziyar
Street address
Tadbir and Omid Sports Complex Swimming Pool, Imam Khomeini Square, Moallem Boulevard
City
Abdanan
Province
Ilam
Postal code
6971751154
Phone
+98 991 331 2953
Email
tadbir.omid.pool@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
Dr. Majid Zamani
Street address
Payame Noor University, Nakhl Street, Artesh Boulevard
City
Tehran
Province
Tehran
Postal code
۱۹۳۹۵۴۶۹۷
Phone
+98 21 2332 0000
Email
zamahani@pnu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Payame Noor 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
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl Street, Artesh Boulevard
City
Tehran
Province
Tehran
Postal code
۱۹۳۹۵۴۶۹۷
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Payame Noor University
Full name of responsible person
Afshin Moghadasi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Injury and Corrective Exercises
Street address
Payame Noor University, Nakhl St, Artesh Blvd, Tehran, Tehran Province, Iran
City
Tehran
Province
Tehran
Postal code
193954697
Phone
+98 21 2332 0000
Email
moghadasi@pnu.ac.ir

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After completion of data analysis, de-identified individual participant data—including demographic information and outcomes related to the primary and secondary variables—will be available upon reasonable written request from qualified researchers, subject to approval by the principal investigator. All identifiable information will be removed or anonymized before sharing.
When the data will become available and for how long
Access to de-identified participant data will be available starting six months after publication of the study results and will remain accessible for five years thereafter.
To whom data/document is available
The data will be available to researchers and academic faculty members from universities or research institutions who have a relevant research proposal and obtain approval from an ethics committee.
Under which criteria data/document could be used
The data may only be used for scientific and educational research purposes. Data use must align with approved research objectives and have prior ethical committee approval. Applicants are required to submit a research proposal, a data use agreement, and a confidentiality commitment. Any commercial use, unauthorized publication, or analysis beyond the approved scope is strictly prohibited.
From where data/document is obtainable
Requests for access to the data or related documents should be addressed to Dr. Afshin Moghaddasi, Assistant Professor, Payame Noor University. Postal Address: Payame Noor University, Nakhl Street, Artesh Boulevard, Tehran, Iran, Postal Code: 193954697 Phone: +982122450000 Email: moghadasi@pnu.ac.ir
What processes are involved for a request to access data/document
The process for requesting data or documents is as follows: 1.The applicant prepares a research proposal along with a data access request form and a confidentiality agreement, and submits them via email to Dr. Afshin Moghaddasi. 2. The request is reviewed by the University Ethics and Research Committee to ensure that the intended use of the data aligns with the study protocol and ethical guidelines. 3. Upon approval, access to the de-identified participant data or requested documents is granted, and the relevant files or download link are sent via email. 4. The entire process typically takes 2 to 4 weeks after receiving the complete request, depending on the data volume and review time.
Comments
All provided data and documents will be accessible after removing any personally identifiable information of participants. Any use of the data must comply with the approved research objectives, and publication of results should cite the original study. Applicants are also required to adhere to all data protection regulations and maintain confidentiality of the information.
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