Progressive Exercise After Operation of Rotator Cuff Rupt... | NCT00624117

Studies
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture

NCT00624117

Sponsor

Jyväskylä Central Hospital

Status

Completed

Last Update Posted

May 27, 2010Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Rotator Cuff Disease
Shoulder Joint

Interventions

Progressive exercise

Countries

Finland

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

May 2010

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

May 2006

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Feb 15, 2008

First Submission Date that Met QC Criteria

Feb 25, 2008

First Posted Date

Feb 26, 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

May 25, 2010

Last Update Posted Date

May 27, 2010Estimated

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 evaluate the effectiveness of progressive strength training after rotator cuff and labrum operation of the shoulder joint.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental		Behavioral: Progressive exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Progressive exercise	Behavioral	home-based exercise program, 2 to 3 exercise sessions per week	A

Measure	Description	Time Frame
Strength and mobility		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rupture of rotator cuff
rupture of anterior labrum
age 18 to 65 years
motivated to continue in work life
motivated for rehabilitation

Exclusion Criteria:

former operation in the same joint
major arthrosis in the same joint
cervical disk herniation
concised spinal cord
conditions after cervical spine operations
rheumatic diseases
fibromyalgia
pregnancy
severe depression
alcoholism
misusing of drugs
disease that prevents progressive exercise eg. back pain, heart disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jari Ylinen, PhD	Jyväskylä Central Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jyväskylä Central Hospital		Jyväskylä		40620	Finland