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Clinical Trials/NCT03227120
NCT03227120CompletedNot Applicable

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

Carilion Clinic2 sites in 1 country60 target enrollmentStarted: July 5, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Change of Six-minute walk test over time

Study Overview

Brief Summary

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.

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
50 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change of Manual muscle tests of hip flexion, extension, abduction; knee flexion, extension and ankle dorsiflexion over time(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(Average of six months: from baseline through completion of the study at approximately three months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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