NCT05426876

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

June 9, 2022

Last Update Submit

July 18, 2022

Conditions

Keywords

ultrasonographyupper extremitysubacromial spaceyoung swimmersmuscle strengthrange of motion

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    up to 32 weeks

Secondary Outcomes (4)

  • Anthropometric measurements

    at baseline

  • Body weight measurement

    at baseline

  • Body Mass Index

    at baseline

  • Body Composition measurement

    at baseline

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Previous upper extremity surgery,
  • Experienced upper extremity pain at least 2 times in the past,
  • Not attending training regularly for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Aykut Özçadırcı, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2022

First Posted

June 22, 2022

Study Start

August 15, 2022

Primary Completion

November 20, 2022

Study Completion

November 20, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share