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

This study has been completed.

Sponsor:

Information provided by:

Jyväskylä Central Hospital

ClinicalTrials.gov Identifier:

NCT00624117

First received: February 15, 2008

Last updated: May 25, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 15, 2008

Last Updated Date

May 25, 2010

Start Date ^ICMJE

May 2006

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Strength and mobility [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00624117 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture: Randomized Controlled Trial

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Rotator Cuff Disease
Shoulder Joint

Intervention ^ICMJE

Behavioral: Progressive exercise

home-based exercise program, 2 to 3 exercise sessions per week

Study Arm (s)

Experimental: A

Intervention: Behavioral: Progressive exercise

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

February 2010

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00624117

Other Study ID Numbers ^ICMJE

Dnro46/2005

Has Data Monitoring Committee

Responsible Party

Jari Ylinen, MD, PhD, Jyväskylä Central Hospital

Study Sponsor ^ICMJE

Jyväskylä Central Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jari Ylinen, PhD

Jyväskylä Central Hospital

Information Provided By

Jyväskylä Central Hospital

Verification Date

May 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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