NCT06552585

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
Last Updated

August 14, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 7, 2024

Last Update Submit

August 10, 2024

Conditions

Keywords

Swimmer's shoulderElastic band programWeight programShoulder rotatorsInjury preventionSwimming

Outcome Measures

Primary Outcomes (1)

  • Peak torque

    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 Outcomes (3)

  • Conventional concentric external/internal shoulder rotators ratio

    12 weeks

  • Functional eccentric external/concentric internal shoulder rotators ratio

    12 weeks

  • Time to peak torque

    12 weeks

Study Arms (3)

Weight program group

EXPERIMENTAL
Other: 12-weeks weight prevention program

Elastic band program group

EXPERIMENTAL
Other: 12-weeks elastic band prevention program

Control

SHAM COMPARATOR
Other: sham intervention

Interventions

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.

Weight program group

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.

Elastic band program group

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.

Control

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Politécnico de Coimbra - RoboCorp

Coimbra, 3045-093, Portugal

Location

Related Publications (1)

  • Tavares N, Vilas-Boas JP, Castro MA. Effect of Preventive Exercise Programs for Swimmer's Shoulder Injury on Rotator Cuff Torque and Balance in Competitive Swimmers: A Randomized Controlled Trial. Healthcare (Basel). 2025 Mar 1;13(5):538. doi: 10.3390/healthcare13050538.

MeSH Terms

Conditions

Shoulder PainAthletic Injuries

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Maria António Castro, PhD

    Instituto Politécnico de Leiria

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
The physiotherapist who carried out the swimmer's interventions was external to the study. The participants were unaware of the existence of other sample groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Care provider and participants blinded, parallel, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 14, 2024

Study Start

September 1, 2022

Primary Completion

November 1, 2022

Study Completion

April 30, 2023

Last Updated

August 14, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations