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

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ClinicalTrials.gov Identifier: NCT00493142
Recruitment Status : Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : September 16, 2016
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta

June 26, 2007
June 28, 2007
September 16, 2016
July 2008
July 2013   (Final data collection date for primary outcome measure)
Self-reported function [ Time Frame: 5 evaluations within 6 months after surgery ]
Same as current
Complete list of historical versions of study NCT00493142 on ClinicalTrials.gov Archive Site
Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction [ Time Frame: 5 evaluations within 6 months after surgery ]
Same as current
Not Provided
Not Provided
 
Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty
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.

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

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoarthritis
  • Rheumatoid Arthritis
Behavioral: Exercise
physical therapy home exercise
Experimental: 1
Usual care
Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
230
June 2017
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00493142
B-060605
No
Not Provided
Not Provided
University of Alberta
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
University of Alberta
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP