Impact of Prehabilitation in Total Knee Replacement

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

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

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Other: Prehabilitation

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Unity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard treatment; 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.
Experimental: Prehabilitation; Prehabilitation:The experimental group will receive a three week prehabilitation program prior to surgery in addition to standard treatment.	Other: Prehabilitation; The three week, 3 days / week prehabilitation exercise program will consist of resistance training, step training and stretching(flexibility) as well as cardiovascular endurance training. Intensity of training will increase over the three weeks. Classes will be delivered over a four week period with a gap during the third week allowing additional time for participants to practice their exercises. The home exercise program will be designed to account for the additional week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six Minute Walk	A valid and reliable measure of total distance walked in six minutes.	Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery
Gait Speed	Gait speed will be measured with the 10 meter walk. It will be assessed under two conditions: 1) instructed to walk at normal speed, 2) instructed to walk as fast as possible.	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Knee Range of Motion (ROM)	Knee ROM (extension and flexion) will be measured with a goniometer at the surgical joint.	Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery
Medical Outcomes Study Short Form-36 (SF-36)	The SF-36 measures 8 dimensions of outcome: physical functioning, social functioning, role-physical, bodily pain, mental health, role-emotional, vitality and general health.	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Sit-to-stand repetitions in 30 seconds	Number of complete stand up to sit down cycles is counted.	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery
Pain	Pain will be measured upon completion of each of the functional tasks (gait speed, six-minute walk and sit to stand) using a Visual Analog Scale from 0 to 10 where 0 is no pain and 10 is severe pain.	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery

Collaborators and Investigators

• Sponsor: Allina Health System
• Investigators: Principal Investigator: Robin Crandall, M.D., Unity Hospital, Allina Health; Principal Investigator: Laura Franco, PT, OCS, Courage Kenny Rehabilitation Institute, Allina Health

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: April 30, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 9, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; Knee Replacement; Prehabilitation
• Other Study ID Numbers: Study 3963-2 IRB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO