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Clinical Trials/NCT01844934
NCT01844934
Completed
Not Applicable

Impact of Prehabilitation in Total Knee Arthroplasty: Outcomes and Healthcare Service Utilization

Allina Health System1 site in 1 country43 target enrollmentJanuary 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
Allina Health System
Enrollment
43
Locations
1
Primary Endpoint
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

A study comparing the benefits of pre-habilitation exercise to standard care prior to total knee arthroplasy

Detailed Description

Recovery post Total Knee Replacement Surgery ((TKA) has been a subject of interest. In a study of 379 patients who had hip or knee replacement surgery, it was reported that at 6 months post-surgery patients with better baseline function had superior functional ability and less pain than patients with lower function at baseline. Another study of 276 patients undergoing TKA reported that pre-operative joint function was a predictor of joint function and overall function at 6 months post-surgery. These findings suggest that prehabilitation to increase functional ability prior to TKA may have a positive effect in recovering post-surgery. In a randomized control trial of patients receiving TKA, the group receiving an Exercise Program (prehabilitation) made significant improvements in performance from baseline to before surgery, and at 1 and 3 months post surgery. For the group that did not receive the Exercise Program pre-surgery, significant improvement did not occur until 3 months post surgery. The overall objective of the proposed single-blinded randomized controlled trial is to demonstrate that a well designed prehabilitation program for patients receiving TKA surgery will significantly improve outcomes related to pain and function and may reduce utilization of health care services post surgery. In this randomized control trial we hypothesize that the group of participants who receive a prehabilitation Exercise Program will recover quicker than patients who do not receive the Exercise Program based on several measures of performance including pain, quadriceps strength, range of motion and quality of life.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
December 1, 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Franco

Physical therapist

Allina Health System

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled to undergo unilateral TKA surgery
  • Ambulatory
  • Community dwelling (living at home)
  • Able to participate in moderate intensity exercise
  • American Society of Anesthesiologists Physical Status Classification(ASA) 1 - 3
  • Speaks English

Exclusion Criteria

  • Patients who are planning a second surgery of the lower limbs during the six months post-surgery
  • Have the effect of peripheral vascular disease or stroke on walking

Outcomes

Primary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Time Frame: Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

WOMAC, a self-assessment tool, is a valid and reliable instrument developed specifically to measure outcomes related to interventions for treatment of the hip and knee. Consisting of three domains: physical, pain and stiffness; a total score is derived by aggregating the domain scores.

Secondary Outcomes

  • Medical Outcomes Study Short Form-36 (SF-36)(Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery)
  • Sit-to-stand repetitions in 30 seconds(Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery)
  • Six Minute Walk(Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery)
  • Gait Speed(Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery)
  • Knee Range of Motion (ROM)(Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery)
  • Pain(Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery)

Study Sites (1)

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