<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03227120</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#2242</org_study_id>
    <nct_id>NCT03227120</nct_id>
  </id_info>
  <brief_title>The Effects of Prehabilitative Exercise on Functional Recovery Following Total Knee Arthroplasty</brief_title>
  <official_title>The Effects of Prehabilitative Exercise on Functional Recovery Following Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carilion Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Radford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Carilion Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to determine the effects of pre-surgery exercise known as&#xD;
      Prehabilitation, on functional outcomes for patients following Total Knee Arthroplasty (TKA)&#xD;
      surgery. The hypothesis is patients that receive effective pre-surgery prehabilitation will&#xD;
      demonstrate improved recovery as measured by the 6-minute walk (6MW) test at one month post&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with knee arthritis have lower levels of physical activity and are more susceptible to&#xD;
      suffer from additional medical conditions of heart disease, respiratory conditions, diabetes&#xD;
      and stroke. For patients with end stage knee osteoarthritis, total knee arthroplasty (TKA)&#xD;
      has been widely accepted as beneficial for increased patient satisfaction and improved&#xD;
      function. To provide high quality of care and optimize TKA outcomes, healthcare providers&#xD;
      need to make decisions about resource allocation. The theory of Prehabilitation proposes to&#xD;
      increase strength, balance and endurance prior to surgery with the benefit of less decline&#xD;
      and improved rate of recovery following surgery. Preoperative quadriceps strength and walking&#xD;
      ability have been shown to be predictive of function one year post operation. However,&#xD;
      systematic reviews of Prehabilitation have been inconclusive and this warrants additional&#xD;
      investigation.&#xD;
&#xD;
      Prior studies of Prehabilitation have been inadequately designed or have low levels of&#xD;
      therapeutic validity. A prior study completed in Spain provided pre-surgical exercise three&#xD;
      times weekly for eight weeks and provides an example of high therapeutic validity with the&#xD;
      corresponding significant results post-operation. The objective of this study is to translate&#xD;
      knowledge of the pre-surgical exercise program completed in Spain into the local context of a&#xD;
      hospital system in Virginia. Due to local area considerations of equipment and time,&#xD;
      modifications of the Spanish pre-surgical exercise program are to be tested. These&#xD;
      adaptations will allow for implementation within American College of Sports Medicine strength&#xD;
      training guidelines using individualized exercise progressions and completion of three clinic&#xD;
      based sessions per week.&#xD;
&#xD;
      Subjects that provide informed consent and complete initial screening will be scheduled for&#xD;
      two pre-surgical and two post-surgical assessment sessions. On the first assessment session,&#xD;
      subjects will be classified into three levels adapted from prior research and input from&#xD;
      clinicians and administration to determine the need for pre-surgical preparation. Those&#xD;
      subjects in the two most severe levels will be asked to participate in a Prehabilitation&#xD;
      exercise program for three times a week for eight weeks and if consent is provided, will be&#xD;
      randomized into the control (Joint Education Home Exercise Class only) or the intervention&#xD;
      exercise program using a gender stratified randomized sequence generated prior to subject&#xD;
      recruitment. The researcher will notify sequential subjects of their group allocation based&#xD;
      on the predetermined randomized sequence at the end of the first testing session.&#xD;
&#xD;
      The goal of the prehabilitative exercise is to provide an individualized exercise program to&#xD;
      be completed 3x/week for 8 weeks. The exercise sessions will be completed in the&#xD;
      rehabilitation office at the Institute of Orthopedics and Neurology (ION) by physical therapy&#xD;
      students with oversight from licensed PT at no cost for each subject. Ongoing evaluation of&#xD;
      each exercise session will use the Borg Rating of Perceived Exertion (RPE) supplemented with&#xD;
      Heart Rate (HR) and Blood Pressure as needed to target the moderate intensity training level&#xD;
      (40-60% HR Max) or above as appropriate to each individual. Weekly evaluation of each&#xD;
      individual's exercise program will be completed and progressed as able. Outline of Exercise&#xD;
      program includes:&#xD;
&#xD;
        -  Warm-up (Low intensity &lt; 40% HR Max) 5 minutes of walking or bike&#xD;
&#xD;
        -  Flexibility: knee flexion/ext and hamstring stretching&#xD;
&#xD;
        -  Strengthening, Balance and Functional activities (Moderate intensity 40-60% HR Max)&#xD;
&#xD;
           o Closed kinetic chain exercises for balance and strengthening: 2-3 sets of 8-20 reps&#xD;
&#xD;
             -  Calf raises unilateral/bilateral&#xD;
&#xD;
             -  Quarter squats progressed to full squats as tolerated&#xD;
&#xD;
             -  Resisted Step Progression (goal of isolated quads)&#xD;
&#xD;
        -  Lunge with and without upper extremity support&#xD;
&#xD;
        -  Step-ups anteriorly&#xD;
&#xD;
        -  Step-downs laterally&#xD;
&#xD;
           ▪ Balance program (goal of Single Leg Stance (SLS) and BOSU wobble board unilateral for&#xD;
           30 seconds)&#xD;
&#xD;
        -  Weight shifts L/R and A/P&#xD;
&#xD;
        -  Standing marching&#xD;
&#xD;
        -  Single leg stance&#xD;
&#xD;
        -  BOSU B maintain stability&#xD;
&#xD;
        -  BOSU B with R/L rocking, A/P rocking&#xD;
&#xD;
        -  BOSU B with quarter squats&#xD;
&#xD;
        -  BOSU Unilateral&#xD;
&#xD;
           o Progressive Resistance exercises with elastic resistance bands 3 sets of 8-12 RM with&#xD;
           2 min rest period between sets:&#xD;
&#xD;
             -  Leg Press bilateral to unilateral (alternate use of total gym or resisted squats)&#xD;
&#xD;
             -  Seated Knee Extensions&#xD;
&#xD;
             -  Standing Knee Curls&#xD;
&#xD;
             -  Elastic band resisted hip ABD L/R (start with side-lying resisted clam shells)&#xD;
&#xD;
        -  Manual therapy according to individual patient needs using a pragmatic approach to&#xD;
           assist with weight bearing activity (for example squats)&#xD;
&#xD;
        -  Cool-down 5 minutes (Low intensity &lt; 40% HR Max) of walking or bike&#xD;
&#xD;
      Statistical comparisons will be conducted using a repeated measures linear mixed model with&#xD;
      group, time and group by time as independent variables. Analyses will be adjusted for age,&#xD;
      gender, BMI and baseline of the outcome measure. The primary outcome will be the 6MW&#xD;
      pre-surgery/pre-exercise compared to one month post-surgery. Secondary outcomes include&#xD;
      relevant clinical metrics (e.g. acute length of stay), impairment measures (e.g. strength),&#xD;
      physical performance tests (e.g. gait speed and the six-minute walk test), physical activity&#xD;
      measured by Actigraph accelerometer, and patient reported outcomes (e.g. PROMIS for global&#xD;
      health). All measures will be collected at four time points:&#xD;
&#xD;
      T1) approximately twelve weeks pre-surgery &amp; before starting the exercise program; T2)&#xD;
      approximately two weeks pre-surgery &amp; after completion of the exercise program; T3) one month&#xD;
      after joint replacement surgery; and T4) three months after joint replacement surgery.&#xD;
&#xD;
      Potential benefits at the individual level include improved recovery of function post TKA,&#xD;
      and improved overall physical activity. Potential benefits at the company/societal level are&#xD;
      improved surgical rehabilitation outcomes including shorter hospital stay, quicker return to&#xD;
      function, and decreased pain. In addition, collaboration between the orthopedists, physical&#xD;
      therapists and administration to implement new methods such as Prehabilitation contribute to&#xD;
      meeting the triple aim of healthcare of improved customer service, higher quality and cost&#xD;
      savings as required by Medicare payment bundling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Six-minute walk test over time</measure>
    <time_frame>Six months: from baseline through completion of the study at approximately three months after surgery</time_frame>
    <description>Assesses distance walked over six minutes at a preferred walking speed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Manual muscle tests of hip flexion, extension, abduction; knee flexion, extension and ankle dorsiflexion over time</measure>
    <time_frame>Average of six months: from baseline through completion of the study at approximately three months after surgery</time_frame>
    <description>Standard muscle testing positions quantified using the MicroFET2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Knee Injury and Osteoarthritis Outcome Score (KOOS) over time</measure>
    <time_frame>Average of six months: from baseline through completion of the study at approximately three months after surgery</time_frame>
    <description>Self-reported outcome questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Arthroplasty</condition>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Prehabilitation Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives Prehabilitation exercise program for three times a week for eight weeks of direct outpatient exercise instruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation exercise</intervention_name>
    <description>Three times weekly exercise program of strengthening, balance and functional activities.&#xD;
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.</description>
    <arm_group_label>Prehabilitation Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  waiting on primary unilateral Total Knee Arthroplasty for knee osteoarthritis&#xD;
&#xD;
          -  agree to participate including completion of a guided exercise program three times per&#xD;
             week for eight weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current tobacco use,&#xD;
&#xD;
          -  body mass index (BMI) greater than 40 kg/m2,&#xD;
&#xD;
          -  pain present in the contralateral limb of 5/10 or more during stair climbing,&#xD;
&#xD;
          -  knee or hip replacement surgery in the previous year.&#xD;
&#xD;
          -  any medical conditions for which moderate or vigorous exercise is contraindicated. For&#xD;
             example uncontrolled stage 2 or 3 hypertension risk group B or C (Pescatello 2004)&#xD;
&#xD;
          -  any disease that severely effects functional performance. For example Stroke or&#xD;
             Parkinson's disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William H Kolb, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Orthopaedics and Neurosciences</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cdc.gov/nchs/data/databriefs/db210.htm.</url>
    <description>Center for Disease Control numbers of joint replacements per year</description>
  </link>
  <link>
    <url>https://www.cdc.gov/arthritis/data_statistics/comorbidities.htm</url>
    <description>Center for Disease Control arthritis and comorbidity statistics</description>
  </link>
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    <PMID>26432986</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>May 15, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>December 2019 or 6 months after the final subject data has been recorded</ipd_time_frame>
    <ipd_access_criteria>Data which have been de-identified will be shared only within the research team.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03227120
org study id: IRB#2242
nct id: NCT03227120
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
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
description: Assesses distance walked over six minutes at a preferred walking speed
measure: 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
description: Standard muscle testing positions quantified using the MicroFET2
measure: 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
description: Self-reported outcome questionnaire
arm group label: Prehabilitation Exercise
arm group type: Experimental
description: Receives Prehabilitation exercise program for three times a week for eight weeks of direct outpatient exercise instruction.
arm group label: Control
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Prehabilitation exercise
description: 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.
arm group label: Prehabilitation Exercise
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William H Kolb, DPT
role: Principal Investigator
affiliation: Radford University
facility: 
country: United States
url: http://www.cdc.gov/nchs/data/databriefs/db210.htm.
description: Center for Disease Control numbers of joint replacements per year
url: https://www.cdc.gov/arthritis/data_statistics/comorbidities.htm
description: Center for Disease Control arthritis and comorbidity statistics
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PMID: 26432986
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd time frame: December 2019 or 6 months after the final subject data has been recorded
ipd access criteria: Data which have been de-identified will be shared only within the research team.