Overview

This trial is active, not recruiting.

Conditions osteoarthritis, rheumatoid arthritis
Treatment exercise
Sponsor University of Alberta
Collaborator Alberta Heritage Foundation for Medical Research
Start date July 2008
End date July 2013
Trial size 240 participants
Trial identifier NCT00493142, B-060605

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Usual care
exercise
physical therapy home exercise

Primary Outcomes

Measure
Self-reported function
time frame: 5 evaluations within 6 months after surgery

Secondary Outcomes

Measure
Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction
time frame: 5 evaluations within 6 months after surgery

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty
Principal investigator Allyson Jones, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University of Alberta.