Shoulder Training: Muscle Recruitment Patterns and the Ef... | NCT00774956

Studies
Shoulder Training: Muscle Recruitment Patterns and the Effect of an Exercise Program

NCT00774956

Sponsor

University Ghent

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

77Actual

Phase

Not Applicable

Conditions

Shoulder Impingement

Interventions

Exercise training program
Exercise training program

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Sep 25, 2008

First Submission Date that Met QC Criteria

Oct 16, 2008

First Posted Date

Oct 17, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Subject with shoulder impingement	Procedure: Exercise training program
2	Active Comparator	Healthy persons	Procedure: Exercise training program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training program	Procedure	A 6 week shoulder exercise training program	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle recruitment pattern		After 6 weeks of training

Secondary Outcomes

Measure	Description	Time Frame
Shoulder pain and functional ability in the patient group		After 6 weeks of training

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement
two positive shoulder impingement tests
pain reproduction during two of three additional categories of clinical tests
the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg

Exclusion Criteria:

cervical and periscapular pain
positive labral injury tests
history of shoulder surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guy Vanderstraeten, MD, PhD	University Ghent	Principal Investigator
Ann Cools, PhD	University Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Ghent		Ghent		9000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D019534	Shoulder Impingement Syndrome

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070599	Shoulder Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided