Pre-operative Rehabilitation Exercise Program for Total Knee Arthroplasty

Rheumatoid Arthritis Clinical Trial

— PREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00493142
• Other study ID #: B-060605
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: November 25, 2021

Study information

• Verified date: July 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: November 25, 2021
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Other:
• Exercise

• Usual care

Locations

Country	Name	City	State
Canada	University of Alberta- Capital Health	Edmonton	Alberta

Sponsors (3)

Lead Sponsor	Collaborator
University of Alberta	Alberta Heritage Foundation for Medical Research, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported function	Self-reported function	5 evaluations within 6 months after surgery
Secondary	Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction	Quality of life	5 evaluations within 6 months after surgery
Secondary	self-efficacy	self-efficacy	5 evaluations within 6 months after surgery
Secondary	ambulation, anxiety and patient satisfaction	ambulation	5 evaluations within 6 months after surgery
Secondary	anxiety	anxiety	5 evaluations within 6 months after surgery
Secondary	patient satisfaction	patient satisfaction	5 evaluations within 6 months after surgery