<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/NCT01708980</url>
  </required_header>
  <id_info>
    <org_study_id>2012-09-TLJ</org_study_id>
    <nct_id>NCT01708980</nct_id>
  </id_info>
  <brief_title>Descriptive Study of Strength Training Exercises to Activate the Muscles of the Operated Leg After Total Knee Replacement</brief_title>
  <official_title>Neuromuscular Activity of the Operated Leg During Strength Training Performed in Machines and in More Simple Forms After Total Knee Replacement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Copenhagen University Hospital, Hvidovre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Copenhagen University Hospital, Hvidovre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      In the early phase after a total knee replacement (TKA), patients experience multi-level&#xD;
      weakness in the operated leg, which is caused primarily by reduced central (CNS) activation&#xD;
      failure of the muscles - especially the knee extensors. This considerable loss of muscle&#xD;
      strength relates to reduced functional performance. The investigators recently reported that&#xD;
      early-commenced physiotherapy, including progressive strength training performed in machines,&#xD;
      seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the&#xD;
      operated leg, elicited during strength training in machines, can be reached during strength&#xD;
      training in more simple forms? Many clinicians are faced with the problem of not having&#xD;
      strength training equipment at their institution, or having to prescribe simple strength&#xD;
      training exercises for home-based training.&#xD;
&#xD;
      Purpose and hypothesis:&#xD;
&#xD;
      The purpose of this study is to determine which strength training exercises that activate the&#xD;
      muscles in the operated leg the most after TKA. The hypothesis is that strength training&#xD;
      exercises performed in machines is more effective compared to strength training performed in&#xD;
      more simple forms (using elastic bands or own body weight, etc.).&#xD;
&#xD;
      Participants and methods:&#xD;
&#xD;
      Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first&#xD;
      investigation, will be included. The participants are investigated twice. During the first&#xD;
      investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a&#xD;
      load that can be lifted exactly 10 times) will be determined for all the exercises. At least&#xD;
      72 hours later, the participants will undergo an electromyographic analysis, which determines&#xD;
      the neuromuscular activity of the thigh muscles in the operated leg.&#xD;
&#xD;
      Ethical issues:&#xD;
&#xD;
      From a pilot study, the investigators found that strength training exercises commenced early&#xD;
      after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain.&#xD;
      None of the financial supporters, or any of the authors, have any potential conflicts of&#xD;
      interest with regard to the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Normalized neuromuscular activity (EMG) of the quadriceps and hamstring muscles</measure>
    <time_frame>One time point, 4 to 8 weeks after TKA</time_frame>
    <description>Normalized electromyographic (EMG) activity (amplitude) during the different exercises. The EMG activity elicited during standardized, maximal contractions is used as a reference for normalization.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>Six different strength training exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six different strength training exercises are investigated. Four repetitions of each exercise are performed with a relative loading of 10 RM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Six different strength training exercises</intervention_name>
    <description>Electromyographic (EMG) activity of the vastus medialis, vastus lateralis, semitendinosus and biceps femoris muscles of the operated leg will be recorded during 6 different strength training exercises. The six exercises performed unilaterally are: seated knee extensions and leg presses in machines (gold standard exercises), and the four other exercises are: sit-to-stands, squats, straight leg raises and seated knee extensions using an elastic band.&#xD;
The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM of the 6 strength training exercises 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>Six different strength training exercises</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 a 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 Research Centre, Copenhagen University Hospital, Hvidovre</name>
      <address>
        <city>Hvidovre</city>
        <state>Copenhagen</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <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>
  </reference>
  <reference>
    <citation>Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.</citation>
    <PMID>21044725</PMID>
  </reference>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 17, 2012</study_first_posted>
  <last_update_submitted>October 22, 2013</last_update_submitted>
  <last_update_submitted_qc>October 22, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 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>Thomas Linding Jakobsen</investigator_full_name>
    <investigator_title>Research Physiotherapist</investigator_title>
  </responsible_party>
  <keyword>Arthroplasty, Replacement, Knee</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Resistance training</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/NCT01708980
org study id: 2012-09-TLJ
nct id: NCT01708980
lead sponsor: 
has dmc: Yes
Background:

      In the early phase after a total knee replacement (TKA), patients experience multi-level
      weakness in the operated leg, which is caused primarily by reduced central (CNS) activation
      failure of the muscles - especially the knee extensors. This considerable loss of muscle
      strength relates to reduced functional performance. The investigators recently reported that
      early-commenced physiotherapy, including progressive strength training performed in machines,
      seems feasible after TKA. The question is, if neuromuscular activity of the muscles in the
      operated leg, elicited during strength training in machines, can be reached during strength
      training in more simple forms? Many clinicians are faced with the problem of not having
      strength training equipment at their institution, or having to prescribe simple strength
      training exercises for home-based training.

      Purpose and hypothesis:

      The purpose of this study is to determine which strength training exercises that activate the
      muscles in the operated leg the most after TKA. The hypothesis is that strength training
      exercises performed in machines is more effective compared to strength training performed in
      more simple forms (using elastic bands or own body weight, etc.).

      Participants and methods:

      Twenty participants with a unilateral TKA, operated between 4 to 8 weeks prior to the first
      investigation, will be included. The participants are investigated twice. During the first
      investigation, the absolute load (kilograms) corresponding to 10 Repetition Maximum (RM) (a
      load that can be lifted exactly 10 times) will be determined for all the exercises. At least
      72 hours later, the participants will undergo an electromyographic analysis, which determines
      the neuromuscular activity of the thigh muscles in the operated leg.

      Ethical issues:

      From a pilot study, the investigators found that strength training exercises commenced early
      after TKA seems feasible as the exercises did not increase knee joint swelling or knee pain.
      None of the financial supporters, or any of the authors, have any potential conflicts of
      interest with regard to the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Normalized neuromuscular activity (EMG) of the quadriceps and hamstring muscles
time frame: One time point, 4 to 8 weeks after TKA
description: Normalized electromyographic (EMG) activity (amplitude) during the different exercises. The EMG activity elicited during standardized, maximal contractions is used as a reference for normalization.
arm group label: Six different strength training exercises
arm group type: Experimental
description: Six different strength training exercises are investigated. Four repetitions of each exercise are performed with a relative loading of 10 RM.
intervention type: Other
intervention name: Six different strength training exercises
description: Electromyographic (EMG) activity of the vastus medialis, vastus lateralis, semitendinosus and biceps femoris muscles of the operated leg will be recorded during 6 different strength training exercises. The six exercises performed unilaterally are: seated knee extensions and leg presses in machines (gold standard exercises), and the four other exercises are: sit-to-stands, squats, straight leg raises and seated knee extensions using an elastic band.
The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM of the 6 strength training exercises 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: Six different strength training exercises
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: 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: Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229.
PMID: 21044725
responsible party type: Principal Investigator
investigator affiliation: Copenhagen University Hospital, Hvidovre
investigator full name: Thomas Linding Jakobsen
investigator title: Research Physiotherapist
mesh term: Osteoarthritis, Knee