Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture
Primary Purpose
Rotator Cuff Disease, Shoulder Joint
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Progressive exercise
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Disease focused on measuring shoulder joint, recovery of function, effectiveness of rehabilitation, rehabilitation
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
Sites / Locations
- Jyväskylä Central Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Strength and mobility
Secondary Outcome Measures
Full Information
NCT ID
NCT00624117
First Posted
February 15, 2008
Last Updated
May 25, 2010
Sponsor
Jyväskylä Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00624117
Brief Title
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture
Official Title
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Jyväskylä Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Disease, Shoulder Joint
Keywords
shoulder joint, recovery of function, effectiveness of rehabilitation, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Progressive exercise
Intervention Description
home-based exercise program, 2 to 3 exercise sessions per week
Primary Outcome Measure Information:
Title
Strength and mobility
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jari Ylinen, PhD
Organizational Affiliation
Jyväskylä Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jyväskylä Central Hospital
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture
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