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Clinical Trials/NCT00493142
NCT00493142
Completed
N/A

Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty

University of Alberta1 site in 1 country240 target enrollmentJuly 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
University of Alberta
Enrollment
240
Locations
1
Primary Endpoint
Self-reported function
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to determine whether a pre-operative home rehabilitation exercise program designed for knee replacements is more effective than pre-operative usual care.

Detailed Description

Patients with lower levels of function prior to total knee arthroplasty (TKA) attain lower functional endpoints after surgery. Therapeutic exercise improves function in patients with arthritis of the knee, yet little evidence has examined the impact of pre-operative exercise for TKA. Single blinded randomized clinical trial comparing a pre-operative home exercise program to pre-operative usual care for patients who are waiting for TKA.Comparison group is usual care within the health region which does not include pre-operative rehabilitation program. Primary outcome: WOMAC function subscale. Secondary outcomes: 1) quality of life; 2) ambulation; 3) self-efficacy; 4) anxiety; 5) patient satisfaction; 6) cost-effectiveness of this intervention. Total Enrollment: 230 patients If the intervention improves function prior to surgery, results will be clinically applicable for patients waiting for surgery

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
November 25, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • primary unilateral total knee arthroplasty
  • poor functional status (WOMAC=50 or greater)
  • 50 yrs or older
  • reside within health region
  • understands English

Exclusion Criteria

  • unicompartmental total knee arthroplasty
  • revision surgery

Outcomes

Primary Outcomes

Self-reported function

Time Frame: 5 evaluations within 6 months after surgery

Self-reported function

Secondary Outcomes

  • Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction(5 evaluations within 6 months after surgery)
  • self-efficacy(5 evaluations within 6 months after surgery)
  • ambulation, anxiety and patient satisfaction(5 evaluations within 6 months after surgery)
  • patient satisfaction(5 evaluations within 6 months after surgery)
  • anxiety(5 evaluations within 6 months after surgery)

Study Sites (1)

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