- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00493142
Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty (PREP)
Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2G4
- University of Alberta- Capital Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
|
Experimental: 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
Sponsor
Collaborators
Investigators
- Principal Investigator: Allyson Jones, PhD, University of Alberta
- Study Director: Lauren Beaupre, PhD, Capital Health- UAH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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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