The Effects of Prehabilitative Exercise on Functional Recovery Following Total Knee Arthroplasty

August 6, 2020 updated by: Carilion Clinic
The primary aim of this study is to determine the effects of pre-surgery exercise known as Prehabilitation, on functional outcomes for patients following Total Knee Arthroplasty (TKA) surgery. The hypothesis is patients that receive effective pre-surgery prehabilitation will demonstrate improved recovery as measured by the 6-minute walk (6MW) test at one month post surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

People with knee arthritis have lower levels of physical activity and are more susceptible to suffer from additional medical conditions of heart disease, respiratory conditions, diabetes and stroke. For patients with end stage knee osteoarthritis, total knee arthroplasty (TKA) has been widely accepted as beneficial for increased patient satisfaction and improved function. To provide high quality of care and optimize TKA outcomes, healthcare providers need to make decisions about resource allocation. The theory of Prehabilitation proposes to increase strength, balance and endurance prior to surgery with the benefit of less decline and improved rate of recovery following surgery. Preoperative quadriceps strength and walking ability have been shown to be predictive of function one year post operation. However, systematic reviews of Prehabilitation have been inconclusive and this warrants additional investigation.

Prior studies of Prehabilitation have been inadequately designed or have low levels of therapeutic validity. A prior study completed in Spain provided pre-surgical exercise three times weekly for eight weeks and provides an example of high therapeutic validity with the corresponding significant results post-operation. The objective of this study is to translate knowledge of the pre-surgical exercise program completed in Spain into the local context of a hospital system in Virginia. Due to local area considerations of equipment and time, modifications of the Spanish pre-surgical exercise program are to be tested. These adaptations will allow for implementation within American College of Sports Medicine strength training guidelines using individualized exercise progressions and completion of three clinic based sessions per week.

Subjects that provide informed consent and complete initial screening will be scheduled for two pre-surgical and two post-surgical assessment sessions. On the first assessment session, subjects will be classified into three levels adapted from prior research and input from clinicians and administration to determine the need for pre-surgical preparation. Those subjects in the two most severe levels will be asked to participate in a Prehabilitation exercise program for three times a week for eight weeks and if consent is provided, will be randomized into the control (Joint Education Home Exercise Class only) or the intervention exercise program using a gender stratified randomized sequence generated prior to subject recruitment. The researcher will notify sequential subjects of their group allocation based on the predetermined randomized sequence at the end of the first testing session.

The goal of the prehabilitative exercise is to provide an individualized exercise program to be completed 3x/week for 8 weeks. The exercise sessions will be completed in the rehabilitation office at the Institute of Orthopedics and Neurology (ION) by physical therapy students with oversight from licensed PT at no cost for each subject. Ongoing evaluation of each exercise session will use the Borg Rating of Perceived Exertion (RPE) supplemented with Heart Rate (HR) and Blood Pressure as needed to target the moderate intensity training level (40-60% HR Max) or above as appropriate to each individual. Weekly evaluation of each individual's exercise program will be completed and progressed as able. Outline of Exercise program includes:

  • Warm-up (Low intensity < 40% HR Max) 5 minutes of walking or bike
  • Flexibility: knee flexion/ext and hamstring stretching

  • Strengthening, Balance and Functional activities (Moderate intensity 40-60% HR Max)

    o Closed kinetic chain exercises for balance and strengthening: 2-3 sets of 8-20 reps

    • Calf raises unilateral/bilateral
    • Quarter squats progressed to full squats as tolerated
    • Resisted Step Progression (goal of isolated quads)
  • Lunge with and without upper extremity support
  • Step-ups anteriorly

  • Step-downs laterally

    ▪ Balance program (goal of Single Leg Stance (SLS) and BOSU wobble board unilateral for 30 seconds)

  • Weight shifts L/R and A/P
  • Standing marching
  • Single leg stance
  • BOSU B maintain stability
  • BOSU B with R/L rocking, A/P rocking
  • BOSU B with quarter squats

  • BOSU Unilateral

    o Progressive Resistance exercises with elastic resistance bands 3 sets of 8-12 RM with 2 min rest period between sets:

    • Leg Press bilateral to unilateral (alternate use of total gym or resisted squats)
    • Seated Knee Extensions
    • Standing Knee Curls
    • Elastic band resisted hip ABD L/R (start with side-lying resisted clam shells)
  • Manual therapy according to individual patient needs using a pragmatic approach to assist with weight bearing activity (for example squats)
  • Cool-down 5 minutes (Low intensity < 40% HR Max) of walking or bike

Statistical comparisons will be conducted using a repeated measures linear mixed model with group, time and group by time as independent variables. Analyses will be adjusted for age, gender, BMI and baseline of the outcome measure. The primary outcome will be the 6MW pre-surgery/pre-exercise compared to one month post-surgery. Secondary outcomes include relevant clinical metrics (e.g. acute length of stay), impairment measures (e.g. strength), physical performance tests (e.g. gait speed and the six-minute walk test), physical activity measured by Actigraph accelerometer, and patient reported outcomes (e.g. PROMIS for global health). All measures will be collected at four time points:

T1) approximately twelve weeks pre-surgery & before starting the exercise program; T2) approximately two weeks pre-surgery & after completion of the exercise program; T3) one month after joint replacement surgery; and T4) three months after joint replacement surgery.

Potential benefits at the individual level include improved recovery of function post TKA, and improved overall physical activity. Potential benefits at the company/societal level are improved surgical rehabilitation outcomes including shorter hospital stay, quicker return to function, and decreased pain. In addition, collaboration between the orthopedists, physical therapists and administration to implement new methods such as Prehabilitation contribute to meeting the triple aim of healthcare of improved customer service, higher quality and cost savings as required by Medicare payment bundling.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Institute for Orthopaedics and Neurosciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • waiting on primary unilateral Total Knee Arthroplasty for knee osteoarthritis
  • agree to participate including completion of a guided exercise program three times per week for eight weeks

Exclusion Criteria:

  • current tobacco use,
  • body mass index (BMI) greater than 40 kg/m2,
  • pain present in the contralateral limb of 5/10 or more during stair climbing,
  • knee or hip replacement surgery in the previous year.
  • any medical conditions for which moderate or vigorous exercise is contraindicated. For example uncontrolled stage 2 or 3 hypertension risk group B or C (Pescatello 2004)
  • any disease that severely effects functional performance. For example Stroke or Parkinson's disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation Exercise
Receives Prehabilitation exercise program for three times a week for eight weeks of direct outpatient exercise instruction.
Other: Prehabilitation exercise

Three times weekly exercise program of strengthening, balance and functional activities.

Weekly evaluation and progression with daily use of the Borg Rating of Perceived Exertion (RPE) supplemented with Heart Rate (HR) and Blood Pressure as needed to target the moderate intensity training level (40-60% HR Max) or above as appropriate to each individual.
No Intervention: Control
Receives the usual standard of care which is a one time Strength and Flexibility written home exercise program provided during total joint education pre-surgery class.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Six-minute walk test over time
Time Frame: Six months: from baseline through completion of the study at approximately three months after surgery
Assesses distance walked over six minutes at a preferred walking speed
Six months: from baseline through completion of the study at approximately three months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Manual muscle tests of hip flexion, extension, abduction; knee flexion, extension and ankle dorsiflexion over time
Time Frame: Average of six months: from baseline through completion of the study at approximately three months after surgery
Standard muscle testing positions quantified using the MicroFET2
Average of six months: from baseline through completion of the study at approximately three months after surgery
Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) over time
Time Frame: Average of six months: from baseline through completion of the study at approximately three months after surgery
Self-reported outcome questionnaire
Average of six months: from baseline through completion of the study at approximately three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

Radford University

Investigators

  • Principal Investigator: William H Kolb, DPT, Radford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

July 21, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 6, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#2242

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All individual participant data (IPD) will be de-identified. All IPD will only be available to members of the research team and stored on a Carilion password protected computer and protected drive. Any data for analysis will be de-identified and only the minimum required for analysis will be provided.

IPD Sharing Time Frame

December 2019 or 6 months after the final subject data has been recorded

IPD Sharing Access Criteria

Data which have been de-identified will be shared only within the research team.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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