Impact of Prehabilitation in Total Knee Replacement

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty

• Registration Number: NCT01844934
• Lead Sponsor: Allina Health System

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 Timeline

• Study First Submitted: 2013-04-30
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Study Start: 2014-01-01
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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 Outcome Measures

Name	Time	Method
Six Minute Walk	Change from baseline to pre-surgery, 4, 14, 26 weeks post-surgery	A valid and reliable measure of total distance walked in six minutes.
Gait Speed	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery	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.
Knee Range of Motion (ROM)	Change from baseline to pre-surgery, 4, 14, and 26 weeks post surgery	Knee ROM (extension and flexion) will be measured with a goniometer at the surgical joint.
Medical Outcomes Study Short Form-36 (SF-36)	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery	The SF-36 measures 8 dimensions of outcome: physical functioning, social functioning, role-physical, bodily pain, mental health, role-emotional, vitality and general health.
Sit-to-stand repetitions in 30 seconds	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery	Number of complete stand up to sit down cycles is counted.
Pain	Change from baseline to pre-surgery, 4, 14 and 26 weeks post surgery	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.

Trial Locations

Locations (1)

Unity Hospital; 🇺🇸 Fridley, Minnesota, United States