Impact of Prehabilitation in Total Knee Replacement

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844934
• Other study ID #: Study 3963-2 IRB
• Status: Completed
• Phase: N/A
• First received: April 30, 2013
• Last updated: February 9, 2017
• Start date: January 1, 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: February 2017
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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.

Locations

Country	Name	City	State
United States	Unity Hospital	Fridley	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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