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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT00493142
First received: June 26, 2007
Last updated: December 17, 2013
Last verified: December 2013

June 26, 2007
December 17, 2013
July 2008
July 2013   (final data collection date for primary outcome measure)
Self-reported function [ Time Frame: 5 evaluations within 6 months after surgery ] [ Designated as safety issue: No ]
Self-reported function [ Time Frame: 5 evaluations within 6 months after surgery ]
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 ] [ Designated as safety issue: No ]
Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction [ Time Frame: 5 evaluations within 6 months after surgery ]
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 Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (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
December 2014
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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00493142
B-060605
No
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
December 2013

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