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Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty (PREP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00493142
Recruitment Status : Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : September 16, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Osteoarthritis Rheumatoid Arthritis Behavioral: Exercise

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
Study Start Date : July 2008
Primary Completion Date : July 2013
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Usual care
Behavioral: Exercise
physical therapy home exercise

Outcome Measures

Primary Outcome Measures :
  1. Self-reported function [ Time Frame: 5 evaluations within 6 months after surgery ]

Secondary Outcome Measures :
  1. Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction [ Time Frame: 5 evaluations within 6 months after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493142

Canada, Alberta
University of Alberta- Capital Health
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Alberta Heritage Foundation for Medical Research
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Allyson Jones, PhD University of Alberta
Study Director: Lauren Beaupre, PhD Capital Health- UAH
More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT00493142     History of Changes
Other Study ID Numbers: B-060605
First Posted: June 28, 2007    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases