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ArthroplastyNCT03227120

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

A study testing Prehabilitation exercise in people with Arthroplasty and Osteoarthritis, Knee, run by Carilion Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Arthroplasty, Osteoarthritis, Knee
What is being tested?
Prehabilitation exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
5 Jul 2017to 31 Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Institute for Orthopaedics and Neurosciences

    Roanoke, Virginia, 24014

Other trials in United States

About this study

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.

Read the 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)
  • 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
  • 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.

Being tested
Prehabilitation exercise
Keywords
Exercise Therapy
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prehabilitation exerciseOther

    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.

Study groups in NCT03227120
Study groupRoleWhat they receive
Prehabilitation ExerciseExperimentalReceives Prehabilitation exercise program for three times a week for eight weeks of direct outpatient exercise instruction.
Receives: Other: Prehabilitation exercise
ControlNo interventionReceives 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Six-minute walk test over time

    Assesses distance walked over six minutes at a preferred walking speed

    Measured: Six months: from baseline through completion of the study at approximately three months after surgery

Secondary outcomes (2)
  1. Change of Manual muscle tests of hip flexion, extension, abduction; knee flexion, extension and ankle dorsiflexion over time

    Standard muscle testing positions quantified using the MicroFET2

    Measured: Average of six months: from baseline through completion of the study at approximately three months after surgery

  2. Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) over time

    Self-reported outcome questionnaire

    Measured: Average of six months: from baseline through completion of the study at approximately three months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2017
  2. Study start5 Jul 2017
  3. Primary completion31 Dec 2019
  4. Study completion31 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized controlled trial with repeated measures pre and post-surgery. Consecutive patients which meet inclusion and exclusion criteria and consent to participate will be evaluated two months or more pre-operatively. After completion of office testing at the pre-surgery/pre-exercise time point, randomization will be completed using a gender stratified randomized sequence generated prior to subject recruitment.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03227120
Sponsor's protocol ID
IRB#2242
Status last verified
Aug 2020
First submitted
15 May 2017
Last updated
7 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Artz N, Elvers KT, Lowe CM, Sackley C, Jepson P, Beswick AD. Effectiveness of physiotherapy exercise following total knee replacement: systematic review and meta-analysis. BMC Musculoskelet Disord. 2015 Feb 7;16:15. doi: 10.1186/s12891-015-0469-6.

    PubMed 25886975
  • Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

    PubMed 20710093
  • Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.

    PubMed 22539338
  • Bade MJ, Struessel T, Dayton M, Foran J, Kim RH, Miner T, Wolfe P, Kohrt WM, Dennis D, Stevens-Lapsley JE. Early High-Intensity Versus Low-Intensity Rehabilitation After Total Knee Arthroplasty: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Sep;69(9):1360-1368. doi: 10.1002/acr.23139. Epub 2017 Aug 13.

    PubMed 27813347
  • Barbay K. Research evidence for the use of preoperative exercise in patients preparing for total hip or total knee arthroplasty. Orthop Nurs. 2009 May-Jun;28(3):127-33. doi: 10.1097/NOR.0b013e3181a46a09.

    PubMed 19494760
  • Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.

    PubMed 19844772
  • Calatayud J, Casana J, Ezzatvar Y, Jakobsen MD, Sundstrup E, Andersen LL. High-intensity preoperative training improves physical and functional recovery in the early post-operative periods after total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2864-2872. doi: 10.1007/s00167-016-3985-5. Epub 2016 Jan 14.

    PubMed 26768606
  • Cabilan CJ, Hines S, Munday J. The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. JBI Database System Rev Implement Rep. 2015 Jan;13(1):146-87. doi: 10.11124/jbisrir-2015-1885.

    PubMed 26447015
  • Caracciolo B, Giaquinto S. Determinants of the subjective functional outcome of total joint arthroplasty. Arch Gerontol Geriatr. 2005 Sep-Oct;41(2):169-76. doi: 10.1016/j.archger.2005.01.005. Epub 2005 Mar 21.

    PubMed 16085068
  • Coudeyre E, Jardin C, Givron P, Ribinik P, Revel M, Rannou F. Could preoperative rehabilitation modify postoperative outcomes after total hip and knee arthroplasty? Elaboration of French clinical practice guidelines. Ann Readapt Med Phys. 2007 Apr;50(3):189-97. doi: 10.1016/j.annrmp.2007.02.002. Epub 2007 Feb 15.

    PubMed 17343953
  • Desmeules F, Hall J, Woodhouse LJ. Prehabilitation improves physical function of individuals with severe disability from hip or knee osteoarthritis. Physiother Can. 2013 Spring;65(2):116-24. doi: 10.3138/ptc.2011-60.

    PubMed 24403671
  • Durrand JW, Batterham AM, Danjoux GR. Pre-habilitation. I: aggregation of marginal gains. Anaesthesia. 2014 May;69(5):403-6. doi: 10.1111/anae.12666. No abstract available.

    PubMed 24738795
  • Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.

    PubMed 21694556
  • Harding P, Holland AE, Delany C, Hinman RS. Do activity levels increase after total hip and knee arthroplasty? Clin Orthop Relat Res. 2014 May;472(5):1502-11. doi: 10.1007/s11999-013-3427-3. Epub 2013 Dec 19.

    PubMed 24353051
  • Hoogeboom TJ, Oosting E, Vriezekolk JE, Veenhof C, Siemonsma PC, de Bie RA, van den Ende CH, van Meeteren NL. Therapeutic validity and effectiveness of preoperative exercise on functional recovery after joint replacement: a systematic review and meta-analysis. PLoS One. 2012;7(5):e38031. doi: 10.1371/journal.pone.0038031. Epub 2012 May 31.

    PubMed 22675429

Questions about this trial

What is this clinical trial studying?

A study testing Prehabilitation exercise in people with Arthroplasty and Osteoarthritis, Knee, run by Carilion Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03227120, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.

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