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Clinical Trials/NCT01844934
NCT01844934CompletedNot Applicable

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

Allina Health System1 site in 1 country43 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
43
Locations
1
Primary Endpoint
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Standard treatment

No Intervention

The no intervention group will receive standard treatment that includes a four hour class pre-surgery consisting of a description of the surgery, what to expect in the hospital and during recovery and some exercises to be done in preparation for surgery.

Prehabilitation

Experimental

Prehabilitation:The experimental group will receive a three week prehabilitation program prior to surgery in addition to standard treatment.

Intervention: Prehabilitation (Other)

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

  • 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)
  • 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)
  • Pain(Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Laura Franco

Physical therapist

Allina Health System

Study Sites (1)

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