Overhead AthletesNCT04254055
Plyometric, Proprioceptive and Strength Exercises in Rugby Players.
A study testing exercises in people with Overhead Athletes, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overhead Athletes
- What is being tested?
- exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 8 Feb 2020to 10 May 2020
- Phase
- Interventional
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Federated rugby players
- Male
- 18 to 45 years old
- Currently participating in regional competitions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Training Program Through Plyometric, Proprioceptive and Strength Exercises in Order to Observe an Improvement of the Strength, Stability and Functional Stability of the Shoulder in Rugby Players
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.
Read more
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.
- Conditions
- Overhead Athletes
- Being tested
- exercises
- Keywords
- Shoulder, Strength, Stability, Functionality, Rugby.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
Also called Experimental group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: exercises |
| Control group | No intervention | Players included in the control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
It will be assessed with the Closed Kinetic Chain Upper Extremity Stability Test. The initial position of the test is a push-up position with the upper extremities perpendicular to the ground. We will use two strips of 3.80 cm tape stuck on the floor and separated 91.44cm apart. The subjects will carry one of the hands until they touch the other strip of tape and return to the initial position. The touches will be counted every time one of the tape strips is touched in a total time of 15 seconds. Each subject will perform a warm-up, followed by 3 attempts with a break between attempts, of 45 seconds, averaging the 3 data obtained.
Measured: 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
The assessment will be carried out with the Simple Shoulder Test. This test is a questionnaire of 12 questions, with two answer options: yes (when the subject is able to perform the task) and no (when he is not able to do it). The results obtained have a scoring range from 0 to 12, with 0 being the lowest functionality and 12 being the highest.
Measured: Screening visit, within the first seven days after treatment and after one month follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start8 Feb 2020
- Primary completion30 Apr 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overhead AthletesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigación en Hemofilia y Fisioterapia
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Rubén Cuesta-Barriuso, PhD, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254055
- Sponsor's protocol ID
- FEF
- Status last verified
- Sep 2021
- First submitted
- 1 Feb 2020
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Training Program Through Plyometric, Proprioceptive and Strength Exercises in Order to Observe an Improvement of the Strength, Stability and Functional Stability of the Shoulder in Rugby Players
- ClinicalTrials.gov ID
- NCT04254055
- Acronym / sponsor ID
- FEF
- Conditions
- Overhead Athletes
- Keywords
- Shoulder, Strength, Stability, Functionality, Rugby.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Investigación en Hemofilia y FisioterapiaResearch network
- Study start
- 8 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 5 Feb 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: exercisesExercise 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. |
| Control group | No intervention | –Players included in the control group will not receive any intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Federated rugby players
- Male
- 18 to 45 years old
- Currently participating in regional competitions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisesAlso: Experimental groupThose 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. | Other | Experimental group |
Primary outcome
Change from baseline strength after treatment and at 1 month
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
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
2 secondary outcomes
Change from baseline stability after treatment and at 1 month
Time frame: 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
Time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
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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.
Rubén Cuesta-Barriuso, PhD principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises in people with Overhead Athletes, run by Investigación en Hemofilia y Fisioterapia at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline strength after treatment and at 1 month (time frame: Screening visit, within the first seven days after treatment and after one month follow-up visit). 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 2 Sep 2021.