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
  Purpose

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.


Condition Intervention
Osteoarthritis
Rheumatoid Arthritis
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Pre-operative Rehabilitation Exercise Program for Patients With Severe Dysfunction Awaiting Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Self-reported function [ Time Frame: 5 evaluations within 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life, self-efficacy, ambulation, anxiety and patient satisfaction [ Time Frame: 5 evaluations within 6 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: July 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Usual care
Behavioral: Exercise
physical therapy home exercise

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493142

Locations
Canada, Alberta
University of Alberta- Capital Health
Edmonton, Alberta, Canada, T6G 2G4
Sponsors and Collaborators
University of Alberta
Alberta Heritage Foundation for Medical Research
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Allyson Jones, PhD University of Alberta
Study Director: Lauren Beaupre, PhD Capital Health- UAH
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT00493142     History of Changes
Other Study ID Numbers: B-060605
Study First Received: June 26, 2007
Last Updated: December 17, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Osteoarthritis
Arthritis
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014