Effect of Two Preventive Exercise Programs for Swimmer's Shoulder on the Torque of Shoulder Rotator Muscles in Competitive Swimmers

August 10, 2024 updated by: Nuno Tavares, School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)

Effect of Two Preventive Exercise Programs for Swimmer's Shoulder on the Torque of Shoulder Rotator Muscles in Competitive Swimmers: a Randomized Controlled Trial

The purpose of this study was to verify the effectiveness of two 12-week preventive exercise programs for swimmer's shoulder with monitoring and progression over time, on the peak torque and respective conventional concentric ratio and functional ratio. One of these programs was performed with weights and the other with an elastic band. This study hypothesized that the two preventive exercise programs minimize shoulder rotators imbalanced during the swimming season. The study design is a care provider and participants blinded, parallel, randomized controlled trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3045-093
        • Instituto Politécnico de Coimbra - RoboCorp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Competitve swimmer in the current season.
  • Aged between 16-35 years old.
  • Have a minimum of 5 years of experience in national competitions.
  • Performed a minimum of 8 hours of weekly swimming training.

Exclusion Criteria:

  • Subjects who had performed at least 6 weeks of treatment such as physical therapy, injections, and medication.
  • Clinical situations such as a history of significant shoulder pain in the last 6 months, a history of traumatic shoulder injuries such as fractures, subluxations, cervical or thoracic conditions, previous shoulder surgeries, shoulder range of motion deficits, or neurological injuries.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control
Other: sham intervention
The control group performed a sham intervention, twice a week, for 12-weeks. This intervention consisted of 2 sets of 10 repetitions of 5 shoulder mobility exercises, without preventive aim, normally carried out in warm-up before training: shoulder maximum flexion and extension, horizontal abduction and adduction starting from 90º of shoulder abduction, maximum internal/external rotation starting from 90º of shoulder abduction, circumduction of the shoulder in a clockwise direction and circumduction of the shoulder in a counterclockwise direction. There was no progression after 6-weeks of this sham intervention. The coach of the respective team checked the execution of the exercises, but there was no individualized monitoring with a regular exercise technique correction by a physiotherapist.
Experimental: Weight program group
Other: 12-weeks weight prevention program
Twice a week, over 12-weeks, the weight program group carried out a strength program with the 5 open kinetic chain exercises most often reported in the literature to prevent swimmer's shoulder - internal rotation at 90°, external rotation at 90°, scapular punches, T's, and Y's - with two weights Domyos with 1, 2, 3, 4, or 5 kg.The load used to perform the programs with weights were previously assessed and adjusted for each swimmer, corresponding to 75% of one repetition maximum. After 6 weeks of program execution, each swimmer carried out another one repetition maximum test assessment, to verify the possibility of a load instrument progression.
Experimental: Elastic band program group
Other: 12-weeks elastic band prevention program
Twice a week, over 12-weeks, the elastic band program group carried out a strength program with the 5 open kinetic chain exercises most often reported in the literature to prevent swimmer's shoulder - internal rotation at 90°, external rotation at 90°, scapular punches, T's, and Y's - with an elastic band Bodytone Power Band with 10, 15, 20, 25, or 30 kg weights Domyos.The load used to perform the programs with weights were previously assessed and adjusted for each swimmer, corresponding to 75% of one repetition maximum. After 6 weeks of program execution, each swimmer carried out another one repetition maximum test assessment, to verify the possibility of a load instrument progression.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak torque
Time Frame: 12 weeks
The concentric and eccentric peak torque of internal and external rotators of the dominant and non-dominant shoulders at 60°/s, 120°/s and 180°/s, evaluated through an isokinetic dynamometer Biodex System 3 (Biodex Medical Systems, New York).
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Conventional concentric external/internal shoulder rotators ratio
Time Frame: 12 weeks
The quotient between peak torque values of the concentric external and internal rotators of the shoulder multiplied by 100.
12 weeks
Functional eccentric external/concentric internal shoulder rotators ratio
Time Frame: 12 weeks
The quotient between peak torque values of the eccentric external rotators of the shoulder and concentric internal rotators of the shoulder multiplied by 100.
12 weeks
Time to peak torque
Time Frame: 12 weeks
The time between the beginning of the torque caption and the peak torque previously described.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Coimbra
Instituto Politécnico de Leiria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria António Castro, PhD, Instituto Politécnico de Leiria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SchoolAHSP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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