<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/NCT01713140</url>
  </required_header>
  <id_info>
    <org_study_id>EA2012_2013</org_study_id>
    <nct_id>NCT01713140</nct_id>
  </id_info>
  <brief_title>Experimental Study of Strength Training to Activate the Quadriceps Muscle After Total Knee Arthroplasty</brief_title>
  <official_title>Central (CNS) Activation of the Quadriceps Muscle During Strength Training With Repetitions to Contraction Failure After Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Progressive strength training is a training modality used in rehabilitation after total knee&#xD;
      arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be&#xD;
      present in the operated leg after TKA, which relates to reduced central nervous system (CNS)&#xD;
      activation of the muscle. As increased CNS activation occurs during strength training when&#xD;
      muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this&#xD;
      also is the case after TKA. The clinical implication is that repetitions performed to&#xD;
      contraction failure during strength training, may help reduce CNS activation deficits of the&#xD;
      quadriceps muscle after TKA.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
      The aim of this study is to investigate CNS activation of the quadriceps muscle during&#xD;
      strength training performed with repetitions to contraction failure after TKA.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL),&#xD;
      semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions&#xD;
      performed in a knee extension machine until contraction failure. The relative loading will be&#xD;
      10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a&#xD;
      minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will&#xD;
      be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure,&#xD;
      etc.) of the set to failure.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA,&#xD;
      the EMG amplitude will increase while the median power frequency will decrease during a&#xD;
      strength training set performed to contraction failure after TKA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from 10% contraction failure in normalized EMG amplitude (%EMGmax).</measure>
    <time_frame>10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.</time_frame>
    <description>EMG amplitude-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from 10% contraction failure in median power frequency (Hz)</measure>
    <time_frame>10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.</time_frame>
    <description>Median power frequency-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (pre strength training) in Nm/kg body mass</measure>
    <time_frame>From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.</time_frame>
    <description>Maximal isometric knee-extension force will be measured, using a fixated hand-held dynamometer, and expressed as the maximal voluntary torque per kilo body mass, using the external lever arm and body weight of each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (pre strength training) in knee pain (VAS-mm)</measure>
    <time_frame>From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.</time_frame>
    <description>Knee pain is scored by each subject at rest and during strength training, using a standard VAS-ruler with endpoints of &quot;no pain&quot; (0 mm) and &quot;worst pain imaginable&quot; (100 mm).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline (pre strength training) in perceived exertion (Borg CR 10 scale points)</measure>
    <time_frame>From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.</time_frame>
    <description>The rate of perceived exertion scale (Borg CR 10) is used to monitor the subjects self-reported experience of exertion.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>1 strength training set performed until contraction failure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Knee extensions until contraction failure will be performed, using a relative loading of 10 repetition maximum (RM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1 strength training set performed until contraction failure</intervention_name>
    <description>Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine in a single set performed until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for.</description>
    <arm_group_label>1 strength training set performed until contraction failure</arm_group_label>
    <other_name>Resistance training.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral primary TKA&#xD;
&#xD;
          -  Between the age of 18 to 80 years&#xD;
&#xD;
          -  Understand and speak Danish&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  4 to 8 weeks after TKA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disease/Musculoskeletal disorder, which requires special rehabilitation modality&#xD;
&#xD;
          -  Alcohol and drug abuse&#xD;
&#xD;
          -  Lack of wish to participate or unwillingness to sign an informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Bandholm, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Reaserch Center, Copenhagen University Hospital, Hvidovre</name>
      <address>
        <city>Copenhagen</city>
        <state>Hvidovre</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Thomas AC, Stevens-Lapsley JE. Importance of attenuating quadriceps activation deficits after total knee arthroplasty. Exerc Sport Sci Rev. 2012 Apr;40(2):95-101. doi: 10.1097/JES.0b013e31824a732b.</citation>
    <PMID>22249398</PMID>
  </reference>
  <results_reference>
    <citation>Jakobsen TL, Husted H, Kehlet H, Bandholm T. Progressive strength training (10 RM) commenced immediately after fast-track total knee arthroplasty: is it feasible? Disabil Rehabil. 2012;34(12):1034-40. doi: 10.3109/09638288.2011.629019. Epub 2011 Nov 15.</citation>
    <PMID>22084974</PMID>
  </results_reference>
  <results_reference>
    <citation>Sundstrup E, Jakobsen MD, Andersen CH, Zebis MK, Mortensen OS, Andersen LL. Muscle activation strategies during strength training with heavy loading vs. repetitions to failure. J Strength Cond Res. 2012 Jul;26(7):1897-903. doi: 10.1519/JSC.0b013e318239c38e.</citation>
    <PMID>21986694</PMID>
  </results_reference>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>June 24, 2013</last_update_submitted>
  <last_update_submitted_qc>June 24, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 25, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Copenhagen University Hospital, Hvidovre</investigator_affiliation>
    <investigator_full_name>Elin Andersson</investigator_full_name>
    <investigator_title>Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>strength training</keyword>
  <keyword>resistance training</keyword>
  <keyword>fatigue</keyword>
  <keyword>knee extension</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>total knee replacement</keyword>
  <keyword>electromyography</keyword>
  <keyword>physical therapy modalities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <!-- 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/NCT01713140
org study id: EA2012_2013
nct id: NCT01713140
lead sponsor: 
collaborator: 
has dmc: Yes
Background:

      Progressive strength training is a training modality used in rehabilitation after total knee
      arthroplasty (TKA). Strength deficits up to 80% in the quadriceps muscle is shown to be
      present in the operated leg after TKA, which relates to reduced central nervous system (CNS)
      activation of the muscle. As increased CNS activation occurs during strength training when
      muscular fatigue is approaching in healthy subjects, it is relevant to investigate if this
      also is the case after TKA. The clinical implication is that repetitions performed to
      contraction failure during strength training, may help reduce CNS activation deficits of the
      quadriceps muscle after TKA.

      Purpose:

      The aim of this study is to investigate CNS activation of the quadriceps muscle during
      strength training performed with repetitions to contraction failure after TKA.

      Method:

      Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL),
      semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions
      performed in a knee extension machine until contraction failure. The relative loading will be
      10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a
      minimum of 3 days before the day where the EMG-data are recorded. The primary outcomes will
      be normalized EMG amplitude and median power frequency for each 10th (10%, 20%, 30% failure,
      etc.) of the set to failure.

      Hypothesis:

      Based on previous findings in healthy subjects, we hypothesize that in patients with a TKA,
      the EMG amplitude will increase while the median power frequency will decrease during a
      strength training set performed to contraction failure after TKA.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change from 10% contraction failure in normalized EMG amplitude (%EMGmax).
time frame: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.
description: EMG amplitude-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.
measure: Change from 10% contraction failure in median power frequency (Hz)
time frame: 10% to 100% contraction failure in a single set performed until contraction failure. The set is performed at a single day, 4 to 8 weeks after surgery.
description: Median power frequency-data from the set performed until contraction failure will be reduced to time points corresponding to 10, 20, 30, 40, 50, 60, 70, 80, 90, and 100% contraction failure.
measure: Change from baseline (pre strength training) in Nm/kg body mass
time frame: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
description: Maximal isometric knee-extension force will be measured, using a fixated hand-held dynamometer, and expressed as the maximal voluntary torque per kilo body mass, using the external lever arm and body weight of each subject.
measure: Change from baseline (pre strength training) in knee pain (VAS-mm)
time frame: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
description: Knee pain is scored by each subject at rest and during strength training, using a standard VAS-ruler with endpoints of "no pain" (0 mm) and "worst pain imaginable" (100 mm).
measure: Change from baseline (pre strength training) in perceived exertion (Borg CR 10 scale points)
time frame: From baseline (pre strength training) to after the set. The set is performed at a single day, 4 to 8 weeks after surgery.
description: The rate of perceived exertion scale (Borg CR 10) is used to monitor the subjects self-reported experience of exertion.
arm group label: 1 strength training set performed until contraction failure
arm group type: Experimental
description: Knee extensions until contraction failure will be performed, using a relative loading of 10 repetition maximum (RM).
intervention type: Other
intervention name: 1 strength training set performed until contraction failure
description: Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine in a single set performed until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for.
arm group label: 1 strength training set performed until contraction failure
other name: Resistance training.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Thomas Bandholm, PhD
role: Study Director
affiliation: Clinical Research Center, Copenhagen University Hospital, Hvidovre, Denmark
facility: 
country: Denmark
citation: Thomas AC, Stevens-Lapsley JE. Importance of attenuating quadriceps activation deficits after total knee arthroplasty. Exerc Sport Sci Rev. 2012 Apr;40(2):95-101. doi: 10.1097/JES.0b013e31824a732b.
PMID: 22249398
citation: Jakobsen TL, Husted H, Kehlet H, Bandholm T. Progressive strength training (10 RM) commenced immediately after fast-track total knee arthroplasty: is it feasible? Disabil Rehabil. 2012;34(12):1034-40. doi: 10.3109/09638288.2011.629019. Epub 2011 Nov 15.
PMID: 22084974
citation: Sundstrup E, Jakobsen MD, Andersen CH, Zebis MK, Mortensen OS, Andersen LL. Muscle activation strategies during strength training with heavy loading vs. repetitions to failure. J Strength Cond Res. 2012 Jul;26(7):1897-903. doi: 10.1519/JSC.0b013e318239c38e.
PMID: 21986694
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Elin Andersson
investigator title: Physiotherapist
mesh term: Osteoarthritis, Knee