NCT04254055

Brief Summary

Introduction. Shoulder injury is the pathology that causes the longest downtime in rugby players, representing 66% of upper limb injuries in this discipline. The lack of strength, and instability are factors that predispose the athlete to suffer this type of dysfunction. The intervention of the study consists of a training program that counteract these dysfunctions. Aim. Assess the effectiveness of a program using plyometric, proprioceptive and strength exercises on 18-45-year-old rugby players to improve strength and stability. Study design. Clinical randomized, prospective, single-blind and trackable. Methods. The subjects included in two study groups, experimental and control, will be attributed a random order. The treatment will last 4 weeks, with 2 weekly sessions, of approximately 25 minutes each. The study variables will be strength, stability and functionality. A descriptive statistical analysis will be carried out calculating the main statistical characteristics. Through of a Kolmogorov analysis the normality of the sample will be assessed. A t-Student test for paired samples will be performed for the difference between the means of the dependent and independent variables. An analysis if variance (ANOVA) for repeated measures will be used to compare the means and checked to what extent the intra-subjects factors influence the dependent variables. Expected results. Improved shoulder strength, stability and functionality for the subjects on which the study is carried out.

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 Feb 2020

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

First Submitted

Initial submission to the registry

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

February 8, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

February 1, 2020

Last Update Submit

September 1, 2021

Conditions

Keywords

ShoulderStrengthStabilityFunctionalityRugby.

Outcome Measures

Primary Outcomes (1)

  • Change from baseline strength after treatment and at 1 month

    The strength assessment will be carried out with a dynamometer. The subject will stand up and the examiner will indicate when the movement should begin. The dynamometer will be positioned to measure the strength of the shoulder abductors and rotators in the position of 90º of abduction and 90º of external rotation. The unit of measure is the Newton

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Secondary Outcomes (2)

  • Change from baseline stability after treatment and at 1 month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

  • Change from baseline functionality after treatment and at 1 month

    Screening visit, within the first seven days after treatment and after one month follow-up visit

Study Arms (2)

Experimental group

EXPERIMENTAL

Exercise 1 with medicine ball. Standing player with 90º shoulder abduction and elbow flexion. He will receive the ball with an external rotation returning it with internal rotation. Exercise 2 with elastic band. From standing, he will fix the elastic band with his foot and perform a shoulder flexion with his contralateral limb. Exercise 3 of iron with support of the hands on the floor and shoulder, elbow and wrist aligned. You should perform a scapula approach and separation without altering its initial position. Exercise 4 BodyBlade ©. From standing with 90º of 90 ° shoulder abduction and elbow flexion. It will perform an anteroposterior thrust, causing a wave effect to stabilize the shoulder joint for 30 seconds. Athletes will do 15 repetitions of each exercise.

Other: exercises

Control group

NO INTERVENTION

Players included in the control group will not receive any intervention.

Interventions

Those subjects included in the experimental group will receive an intervention through a program with plyometric, proprioceptive and strength exercises. The subjects included in the control group will not receive any intervention.

Also known as: Experimental group
Experimental group

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Federated rugby players
  • Male
  • to 45 years old
  • Currently participating in regional competitions

You may not qualify if:

  • Being treated with anti-inflammatory drugs
  • Having suffered an upper limb injury in the month prior to the intervention
  • Have undergone surgery for any shoulder pathology during the previous 12 months
  • Who have suffered or suffer from a serious and / or metabolic disease
  • That they have not signed the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Madrid

Madrid, Spain

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rubén Cuesta-Barriuso, PhD

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 5, 2020

Study Start

February 8, 2020

Primary Completion

April 30, 2020

Study Completion

May 10, 2020

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations