Shoulder InjuryPhase 2NCT00998777
Shoulder Injury Prevention Program in Swimmers
A Phase 2 study testing Shoulder Strengthening in people with Shoulder Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder strengthening and stretching program in… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Injury
- What is being tested?
- Shoulder Strengthening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2010
- Phase
- Phase 2
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be included in the study if they meet the following criteria:
- NCAA division I swimmers
- Participate in swimming for at least 30 minutes per day for 4 days per week.
- Participate in all team weight lifting sessions.
- Complete 15 of the 18 training sessions if the subject is placed in the treatment group.
Who cannot join
- Subjects will be excluded from the study if:
- They are currently being treated for shoulder pain
- They develop shoulder pain during the course of the intervention program
Trial locations and contacts
1 site in 1 country.
United States1 site
Dean E. Smith Center
Chapel Hill, North Carolina, 27510
About this study
Official title: The Effect of a 6-week Shoulder Strengthening Program on Scapular Kinematics and Shoulder Strength in Division I Collegiate Swimmers
The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder strengthening and stretching program in division I collegiate swimmers. The result of this study may demonstrate the effectiveness of a strengthening and stretching program to positively influence factors that have been associated with pain and injury in division I collegiate swimmers and indicate the need to implement this program for the entire team. Following a 6-week strengthening and stretching program, it is believed that scapular kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be improved compared to control subjects.
- Conditions
- Shoulder Injury
- Being tested
- Shoulder Strengthening
- Keywords
- tubing program, shoulder strengthening, injury prevention
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder StrengtheningProcedure or surgery
Also called Shoulder injury prevention, tubing program for athletes
The intervention program is a 6 week shoulder and scapular stabilizer strengthening program that is performed 3 times per week. The program includes 10 exercises that are performed with Theraband rubber tubing and 2 stretches. The exercises are: shoulder flexion, Ys, Ts, Ws, IR @ 90, ER @ 90, Throwing acceleration, Throwing deceleration, dynamic hug, and low rows. The stretches include the sleeper stretch and the corner stretch.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Strengthening | Experimental | The shoulder strengthening program is a 6-week intervention aimed to improve shoulder and scapular stabilizer strength and scapular kinematics. The program includes 10 exercises: shoulder flexion, Ys,Ts,Ws, Throwing Acceleration, Throwing Deceleration, Low Rows, Dynamic Hug, IR @ 90, and ER @ 90. The program also includes 2 stretches: sleeper stretch and corner stretch. Receives: Procedure: Shoulder Strengthening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder and Scapular Stabilizer Strength
Measured: Measured pre and post test
Secondary outcomes (4)
Scapular Kinematics
Measured: Measured pre and post test
Shoulder ROM
Measured: Measured pre and post test
Postural Assessment
Measured: Measured pre and post test
Width of subacromial space
Measured: Measured pre and post test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuryStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Hibberd, Principal investigator, UNC-Chapel HillJoseph B Myers, PhD, ATC, Study director, UNC- Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998777
- Sponsor's protocol ID
- SwimmersShoulder
- Status last verified
- Jan 2012
- First submitted
- 19 Oct 2009
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 6-week Shoulder Strengthening Program on Scapular Kinematics and Shoulder Strength in Division I Collegiate Swimmers
- ClinicalTrials.gov ID
- NCT00998777
- Acronym / sponsor ID
- SwimmersShoulder
- Conditions
- Shoulder Injury
- Keywords
- tubing program, shoulder strengthening, injury prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 20 Oct 2009 (estimated)
- 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.
The primary purpose of this study is to assess changes in shoulder muscle strength, shoulder movement, shoulder flexibility, muscle thickness, upper arm torsion angle, and subacromial width (space where the rotator cuff muscle passes through) after completing a 6-week shoulder strengthening and stretching program in division I collegiate swimmers. The result of this study may demonstrate the effectiveness of a strengthening and stretching program to positively influence factors that have been associated with pain and injury in division I collegiate swimmers and indicate the need to implement this program for the entire team. Following a 6-week strengthening and stretching program, it is believed that scapular kinematics, shoulder flexibility, and shoulder and scapular stabilizer strength will be improved compared to control subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Strengthening | Experimental | Procedure: Shoulder StrengtheningThe shoulder strengthening program is a 6-week intervention aimed to improve shoulder and scapular stabilizer strength and scapular kinematics. The program includes 10 exercises: shoulder flexion, Ys,Ts,Ws, Throwing Acceleration, Throwing Deceleration, Low Rows, Dynamic Hug, IR @ 90, and ER @ 90. The program also includes 2 stretches: sleeper stretch and corner stretch. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects will be included in the study if they meet the following criteria:
Key exclusion criteria (3 listed)
- Subjects will be excluded from the study if:
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 |
|---|---|---|
| Shoulder StrengtheningAlso: Shoulder injury prevention, tubing program for athletesThe intervention program is a 6 week shoulder and scapular stabilizer strengthening program that is performed 3 times per week. The program includes 10 exercises that are performed with Theraband rubber tubing and 2 stretches. The exercises are: shoulder flexion, Ys, Ts, Ws, IR @ 90, ER @ 90, Throwing acceleration, Throwing deceleration, dynamic hug, and low rows. The stretches include the sleeper stretch and the corner stretch. | Procedure or surgery | Shoulder Strengthening |
Primary outcome
Shoulder and Scapular Stabilizer Strength
Time frame: Measured pre and post test
4 secondary outcomes
Scapular Kinematics
Time frame: Measured pre and post test
Shoulder ROM
Time frame: Measured pre and post test
Postural Assessment
Time frame: Measured pre and post test
Width of subacromial space
Time frame: Measured pre and post test
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 11 Jan 2012.
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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.
Elizabeth Hibberd principal investigator
UNC-Chapel Hill
Joseph B Myers, PhD, ATC study director
UNC- Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Shoulder Strengthening in people with Shoulder Injury, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 5 inclusion and 3 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 11 Jan 2012. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Shoulder and Scapular Stabilizer Strength (time frame: Measured pre and post test). 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 11 Jan 2012; AzTrials last refreshed its copy on 1 Nov 2026.