ImageNCT05426876
The Effect of Competition Season on Physical Characteristic and Shoulder Periarticular Structures in Swimmers
An observational study of Image and Athletic Injuries, run by Hacettepe University.
Trial summary
The aim of this study is to investigate the effect of a competition season on shoulder periarticular structures, muscle strength, muscle endurance, joint range of motion and upper extremity performance in young swimmers. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Image, Athletic Injuries, Upper Extremity
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 20 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: In this study, volunteer swimmers who practice swimming professionally in Ankara University Sports Club will be evaluated and included in the study. In determining the sample size of the study, Tate et al. Data showing the difference in shoulder joint range of motion were used. As a result of the power analysis, it was determined that 23 participants should be included in such a way that the type 1 error was 5% and the power of the study was at least 95%. Considering the possibility of participants leaving the study during the study period, 30 swimmers were planned to be included in the study. Posthoc power analysis will be done with the data to be obtained after the study.
Who may be able to join
- To be between the ages of 10-15
- At least 6 hours of swimming training per week,
- Individuals do not have cooperation and communication problems,
- Individuals volunteer to participate in the study.
Who cannot join
- Previous upper extremity surgery,
- Experienced upper extremity pain at least 2 times in the past,
- Not attending training regularly for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Competition Season on Shoulder Periarticular Structures, Muscle Strength, Range of Motion, Scapular Muscle Endurance and Upper Extremity Performance in Young Swimmers
The aim of this study is to investigate the effect of a competition season on shoulder periarticular structures, muscle strength, muscle endurance, joint range of motion and upper extremity performance in young swimmers.
Read the detailed description
After being informed about the study, all swimmers giving written informed consent will undergo a 1- week screening period to determine eligibility for study entry. Swimmers who meet the eligibility requirements will be evaluated 3 times: pre-season, mid-season, and post-season.
- Conditions
- Image, Athletic Injuries, Upper Extremity
- Keywords
- ultrasonography, upper extremity, subacromial space, young swimmers, muscle strength, range of motion
- Medical subject headings
- Athletic Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in shoulder periarticular structures during training season
Measurements will be made by a medical physician with at least 4 years of experience in musculoskeletal ultrasonography. The participants will be placed in a position called the Crass position, where the arm is in extension, adduction, and internal rotation, and the dorsal aspect of the hand is placed on the lumbar region.
Deltoid muscle thickness: The thickness of the muscle tissue between the skin and subcutaneous tissue and the supraspinatus tendon will be measured from the point where it is thickest.
Supraspinatus tendon thickness: The supraspinatus muscle, which is between the deltoid muscle and the humerus-articular cartilage, will be measured at its thickest point.
Cartilage thickness of the humeral head: Articular cartilage thickness, which is seen anechoic between the humerus and the supraspinatus tendon, will be measured from the midpoint.
Acromiohumeral distance: The distance between the humerus and acromion will be measured in the neutral position.
Measured: up to 32 weeks
Changes in muscle strength during the training season
Isometric muscle strength will be measured with a hand dynamometer. Before starting the measurement, the participants will be informed verbally about the technique of practice of the test. In order to ensure correct movement, individuals will be asked to perform a submaximal contraction against the evaluator's hand before the test and the measurements will be taught. The "break test" technique, which requires isometric contraction, will be applied during the tests. During the break test, the person performing the test pushes the dynamometer towards the patient's extremity until the movement is released in the relevant joint in a way that can overcome the maximum muscle strength.
Bilateral shoulder flexion, extension, internal rotation, and external rotation muscle strength and serratus anterior, middle, and lower trapezius will be measured and averaged in 3 repetitions and recorded in "kg". A 30-second rest will be given between measurements.
Measured: up to 32 weeks
Changes in Shoulder Range of Motion during training season
Both shoulder joint flexion, extension, internal and external rotation normal joint movements will be measured and recorded in degrees with a digital goniometer.
Measured: up to 32 weeks
Changes in Upper Extremity Functional Performance during training season
The closed kinetic chain upper extremity stabilization test, which is a dynamic test, is used to evaluate potential strength and muscular strength deficits, as well as proprioception and motor control. The test is performed in a modified push-up position with elbows straight and knees bent. When the test is started, they will be asked to raise one of their hands and touch the other hand, and the number of times the athletes touched their hands within 15 seconds will be recorded.
Measured: up to 32 weeks
Assessment of Scapular Muscle Endurance
Muscle endurance will be assessed using the posterior shoulder endurance test. While the measurement is lying prone, participants will be asked to actively raise their arms to a horizontal position at an angle of 135 ('Y' position). A movable clamp to be placed on a vertically oriented metal bar will be set to mark the point where the radial direction of the wrist contacts the horizontal bar. The swimmer will then lift a dumbbell of 1.0 or 1.5 kg (2% of body weight) and hold it at the final point and the holding time will be recorded with the stopwatch. The test will begin when the swimmer's wrist is in contact with the clamp and will be terminated if compensation occurs, such as loss of arm contact with the bar or trunk rotation.
Measured: up to 32 weeks
Secondary outcomes (4)
Anthropometric measurements
Participants' height in cm will be measured. In addition, parameters such as arm span, shoulder width, arm length, and sitting and standing height will be measured in cm and recorded.
Measured: at baseline
Body weight measurement
The body weight of the participants will be measured and recorded in kilograms.
Measured: at baseline
Body Mass Index
Body mass index is obtained by dividing the body weight in kilograms by the square of the height in meters. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared.
Measured: at baseline
Body Composition measurement
Body composition will be evaluated with a bioelectrical impedance analyzer (BIA) device InBody 120 (IB120) (InBody USA) with tetrapolar-8 point tactile electrodes. The participants will step on the scale with bare feet and light clothes, aligning their heels and feet with the electrodes on the measuring scale, to ensure maximum contact area, and they will be asked to stand still while their body mass is measured. To ensure that the arms do not touch the trunk during the measurement, the participants will be positioned with the elbows in full extension and the arms in approximately. The device has two frequencies (20 and 100 kHz) for impedance measurement in five body segments (four extremities and trunk). Body composition parameters used; total body muscle mass (SMM; in kg), the lean mass of five body segments (FFM; in kg) and total body fat mass (BFM; in kg), and fat mass of five body segments.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start15 Aug 2022 (estimated)
- Primary completion20 Nov 2022 (estimated)
- Study completion20 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImageStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aykut OZCADIRCI, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426876
- Sponsor's protocol ID
- GO21/1341
- Status last verified
- Jul 2022
- First submitted
- 9 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Competition Season on Shoulder Periarticular Structures, Muscle Strength, Range of Motion, Scapular Muscle Endurance and Upper Extremity Performance in Young Swimmers
- ClinicalTrials.gov ID
- NCT05426876
- Acronym / sponsor ID
- GO21/1341
- Conditions
- Image, Athletic Injuries, Upper Extremity
- Keywords
- ultrasonography, upper extremity, subacromial space, young swimmers, muscle strength, range of motion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effect of a competition season on shoulder periarticular structures, muscle strength, muscle endurance, joint range of motion and upper extremity performance in young swimmers.
Detailed description
After being informed about the study, all swimmers giving written informed consent will undergo a 1- week screening period to determine eligibility for study entry. Swimmers who meet the eligibility requirements will be evaluated 3 times: pre-season, mid-season, and post-season.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- In this study, volunteer swimmers who practice swimming professionally in Ankara University Sports Club will be evaluated and included in the study. In determining the sample size of the study, Tate et al. Data showing the difference in shoulder joint range of motion were used. As a result of the power analysis, it was determined that 23 participants should be included in such a way that the type 1 error was 5% and the power of the study was at least 95%. Considering the possibility of participants leaving the study during the study period, 30 swimmers were planned to be included in the study. Posthoc power analysis will be done with the data to be obtained after the study.
Key inclusion criteria (4 listed)
- To be between the ages of 10-15
- At least 6 hours of swimming training per week,
- Individuals do not have cooperation and communication problems,
- Individuals volunteer to participate in the study.
Key exclusion criteria (3 listed)
- Previous upper extremity surgery,
- Experienced upper extremity pain at least 2 times in the past,
- Not attending training regularly for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in shoulder periarticular structures during training season
Time frame: up to 32 weeks
Measurements will be made by a medical physician with at least 4 years of experience in musculoskeletal ultrasonography. The participants will be placed in a position called the Crass position, where the arm is in extension, adduction, and internal rotation, and the dorsal aspect of the hand is placed on the lumbar region. Deltoid muscle thickness: The thickness of the muscle tissue between the skin and subcutaneous tissue and the supraspinatus tendon will be measured from the point where it is thickest. Supraspinatus tendon thickness: The supraspinatus muscle, which is between the deltoid muscle and the humerus-articular cartilage, will be measured at its thickest point. Cartilage thickness of the humeral head: Articular cartilage thickness, which is seen anechoic between the humerus and the supraspinatus tendon, will be measured from the midpoint. Acromiohumeral distance: The distance between the humerus and acromion will be measured in the neutral position.
Changes in muscle strength during the training season
Time frame: up to 32 weeks
Isometric muscle strength will be measured with a hand dynamometer. Before starting the measurement, the participants will be informed verbally about the technique of practice of the test. In order to ensure correct movement, individuals will be asked to perform a submaximal contraction against the evaluator's hand before the test and the measurements will be taught. The "break test" technique, which requires isometric contraction, will be applied during the tests. During the break test, the person performing the test pushes the dynamometer towards the patient's extremity until the movement is released in the relevant joint in a way that can overcome the maximum muscle strength. Bilateral shoulder flexion, extension, internal rotation, and external rotation muscle strength and serratus anterior, middle, and lower trapezius will be measured and averaged in 3 repetitions and recorded in "kg". A 30-second rest will be given between measurements.
Changes in Shoulder Range of Motion during training season
Time frame: up to 32 weeks
Both shoulder joint flexion, extension, internal and external rotation normal joint movements will be measured and recorded in degrees with a digital goniometer.
Changes in Upper Extremity Functional Performance during training season
Time frame: up to 32 weeks
The closed kinetic chain upper extremity stabilization test, which is a dynamic test, is used to evaluate potential strength and muscular strength deficits, as well as proprioception and motor control. The test is performed in a modified push-up position with elbows straight and knees bent. When the test is started, they will be asked to raise one of their hands and touch the other hand, and the number of times the athletes touched their hands within 15 seconds will be recorded.
Assessment of Scapular Muscle Endurance
Time frame: up to 32 weeks
Muscle endurance will be assessed using the posterior shoulder endurance test. While the measurement is lying prone, participants will be asked to actively raise their arms to a horizontal position at an angle of 135 ('Y' position). A movable clamp to be placed on a vertically oriented metal bar will be set to mark the point where the radial direction of the wrist contacts the horizontal bar. The swimmer will then lift a dumbbell of 1.0 or 1.5 kg (2% of body weight) and hold it at the final point and the holding time will be recorded with the stopwatch. The test will begin when the swimmer's wrist is in contact with the clamp and will be terminated if compensation occurs, such as loss of arm contact with the bar or trunk rotation.
4 secondary outcomes
Anthropometric measurements
Time frame: at baseline
Body weight measurement
Time frame: at baseline
Body Mass Index
Time frame: at baseline
Body Composition measurement
Time frame: at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Image and Athletic Injuries, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aykut Özçadırcı, M.Sc. (+903123052525, aykutozcadirci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in shoulder periarticular structures during training season (time frame: up to 32 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.