NCT00624117

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

May 1, 2010

Enrollment Period

2.8 years

First QC Date

February 15, 2008

Last Update Submit

May 25, 2010

Conditions

Rotator Cuff DiseaseShoulder Joint

Keywords

shoulder jointrecovery of functioneffectiveness of rehabilitationrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Strength and mobility

    one year

Study Arms (1)

A

EXPERIMENTAL
Behavioral: Progressive exercise

Interventions

Progressive exerciseBEHAVIORAL

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

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jyväskylä Central Hospital

Jyväskylä, 40620, Finland

Location

Study Officials

  • Jari Ylinen, PhD

    Jyväskylä Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 15, 2008

First Posted

February 26, 2008

Study Start

May 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2010

Last Updated

May 27, 2010

Record last verified: 2010-05

Locations

FI(1)