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

July 13, 2022 updated by: University of Alberta

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2G4
        • University of Alberta- Capital Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care
Other: Usual care
Experimental: Exercise
Other: Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported function
Time Frame: 5 evaluations within 6 months after surgery
Self-reported function
5 evaluations within 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction
Time Frame: 5 evaluations within 6 months after surgery
Quality of life
5 evaluations within 6 months after surgery
self-efficacy
Time Frame: 5 evaluations within 6 months after surgery
self-efficacy
5 evaluations within 6 months after surgery
ambulation, anxiety and patient satisfaction
Time Frame: 5 evaluations within 6 months after surgery
ambulation
5 evaluations within 6 months after surgery
anxiety
Time Frame: 5 evaluations within 6 months after surgery
anxiety
5 evaluations within 6 months after surgery
patient satisfaction
Time Frame: 5 evaluations within 6 months after surgery
patient satisfaction
5 evaluations within 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

Canadian Institutes of Health Research (CIHR)
Alberta Heritage Foundation for Medical Research

Investigators

  • Principal Investigator: Allyson Jones, PhD, University of Alberta
  • Study Director: Lauren Beaupre, PhD, Capital Health- UAH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

November 25, 2021

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 28, 2007

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 13, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-060605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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