<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/NCT01729520</url>
  </required_header>
  <id_info>
    <org_study_id>BA-2012-BR</org_study_id>
    <nct_id>NCT01729520</nct_id>
  </id_info>
  <brief_title>Descriptive Study of Knee Joint Pain During Strength Training After Total Knee Arthroplasty</brief_title>
  <official_title>Knee Joint Pain During Strength Training After Total Knee Arthroplasty: Effect of Loading and Repetitions to Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      In the early phase after a total knee arthroplasty (TKA), patients experience multi-level&#xD;
      weakness in the operated leg, which is caused primarily by reduced central nervous system&#xD;
      (CNS) activation failure of the muscles - especially the knee extensors. This considerable&#xD;
      loss of muscle strength relates to reduced functional performance. Early-commenced,&#xD;
      progressive strength training of the knee extensors of the operated leg therefore seems&#xD;
      rational. However, the concern is that this type of early-commenced, intense physical&#xD;
      rehabilitation exacerbates post-operative symptoms, such as knee joint pain.&#xD;
&#xD;
      The investigators have recently reported that early-commenced physical rehabilitation,&#xD;
      including progressive strength training of the knee extensors of the operated leg seems&#xD;
      feasible after TKA. The classic exercise-physiology literature emphasizes loading and&#xD;
      repetitions performed to contraction failure - among others - as important variables for&#xD;
      muscle hypertrophy and strength gains. It is currently not known how loading and repetitions&#xD;
      performed to contraction failure during knee extensions with the operated leg, influences&#xD;
      post-operative knee joint pain in patients with TKA.&#xD;
&#xD;
      Purpose and hypothesis:&#xD;
&#xD;
      The purpose of this study is to investigate how loading and repetitions to contraction&#xD;
      failure influence knee joint pain during knee extensions with the operated leg early after&#xD;
      TKA.&#xD;
&#xD;
      The hypothesis is that knee pain increases with increasing loading and fatigue.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Fifteen patients with a unilateral TKA, operated between 1 to 2 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 unilateral (operated leg)&#xD;
      knee extension. At the second investigation, at least 72 hours later, the patients will&#xD;
      perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a&#xD;
      randomized order, estimated from their 10 RM test at the first investigation. Time under&#xD;
      tension (contraction velocity) and range of knee joint motion for each repetition will be&#xD;
      controlled for. During the concentric phase of each repetition, the patients rate their knee&#xD;
      joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a&#xD;
      short break, the patients perform 1 set of knee extension with a relative loading of 10 RM&#xD;
      until of contraction failure. As for the loading effect described above, they rate their knee&#xD;
      joint pain during the concentric phase of each repetition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Load experiment: Difference (in numerical rating scale points) between 20 RM, 14 RM, and 8 RM loadings, in knee joint pain during knee extensions.</measure>
    <time_frame>Four repetitions at 20 RM, 14 RM, and 8 RM loadings. The strength training sets are performed at a single day, 1 to 2 weeks after surgery.</time_frame>
    <description>A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Failure experiment: Change (in numerical rating scale points) from 10% contraction failure in knee joint pain during knee extensions.</measure>
    <time_frame>10% to 100% contraction failure in a single strength training set performed until contraction failure. The strength training set is performed at a single day, 1 to 2 weeks after surgery.</time_frame>
    <description>A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline (pre strength training) in resting knee joint pain (numerical rating scale points).</measure>
    <time_frame>From baseline (pre strength training) to after the strength training sets. The strength training sets are performed at a single day,1 to 2 weeks after surgery.</time_frame>
    <description>A 0-10 numerical rating scale is used to rate knee joint pain at rest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee joint pain (in numerical rating scale points) during activities of daily living</measure>
    <time_frame>Before the strength training sets at a single day,1 to 2 weeks after surgery.</time_frame>
    <description>Knee joint pain is rated during standing and walking, using a 0-10 numerical rating scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Knee extension strength training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Knee extension strength training</intervention_name>
    <description>Load experiment: Four knee extensions will be performed with the operated leg at 20, 14, and 8 RM loadings each, in a randomized order. Range of knee joint motion and time under tension for each repetition will be controlled for&#xD;
Failure experiment: One strength training set of knee extensions will be performed with the operated leg at 10 RM loading until contraction failure. Range of knee joint motion and time under tension for each repetition will be controlled for</description>
    <arm_group_label>Knee extension strength training</arm_group_label>
  </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;
          -  1 to 2 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, Copenhagen, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Center (136), Copenhagen University Hospital, Hvidovre</name>
      <address>
        <city>Hvidovre</city>
        <state>Copenhagen</state>
        <zip>DK-2500</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 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>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Thomas Bandholm</investigator_full_name>
    <investigator_title>Senior Researcher, PhD</investigator_title>
  </responsible_party>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Total knee replacement</keyword>
  <keyword>Strength training</keyword>
  <keyword>Resistance training</keyword>
  <keyword>Physical therapy modalities</keyword>
  <keyword>Fatigue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthralgia</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/NCT01729520
org study id: BA-2012-BR
nct id: NCT01729520
lead sponsor: 
has dmc: Yes
Background:

      In the early phase after a total knee arthroplasty (TKA), patients experience multi-level
      weakness in the operated leg, which is caused primarily by reduced central nervous system
      (CNS) activation failure of the muscles - especially the knee extensors. This considerable
      loss of muscle strength relates to reduced functional performance. Early-commenced,
      progressive strength training of the knee extensors of the operated leg therefore seems
      rational. However, the concern is that this type of early-commenced, intense physical
      rehabilitation exacerbates post-operative symptoms, such as knee joint pain.

      The investigators have recently reported that early-commenced physical rehabilitation,
      including progressive strength training of the knee extensors of the operated leg seems
      feasible after TKA. The classic exercise-physiology literature emphasizes loading and
      repetitions performed to contraction failure - among others - as important variables for
      muscle hypertrophy and strength gains. It is currently not known how loading and repetitions
      performed to contraction failure during knee extensions with the operated leg, influences
      post-operative knee joint pain in patients with TKA.

      Purpose and hypothesis:

      The purpose of this study is to investigate how loading and repetitions to contraction
      failure influence knee joint pain during knee extensions with the operated leg early after
      TKA.

      The hypothesis is that knee pain increases with increasing loading and fatigue.

      Methods:

      Fifteen patients with a unilateral TKA, operated between 1 to 2 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 unilateral (operated leg)
      knee extension. At the second investigation, at least 72 hours later, the patients will
      perform 1 set of 4 repetitions with a relative loading of 8, 14, and 20 RM each, in a
      randomized order, estimated from their 10 RM test at the first investigation. Time under
      tension (contraction velocity) and range of knee joint motion for each repetition will be
      controlled for. During the concentric phase of each repetition, the patients rate their knee
      joint pain verbally, using a numerical rating scale placed 1 meter in front of them. After a
      short break, the patients perform 1 set of knee extension with a relative loading of 10 RM
      until of contraction failure. As for the loading effect described above, they rate their knee
      joint pain during the concentric phase of each repetition.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Load experiment: Difference (in numerical rating scale points) between 20 RM, 14 RM, and 8 RM loadings, in knee joint pain during knee extensions.
time frame: Four repetitions at 20 RM, 14 RM, and 8 RM loadings. The strength training sets are performed at a single day, 1 to 2 weeks after surgery.
description: A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.
measure: Failure experiment: Change (in numerical rating scale points) from 10% contraction failure in knee joint pain during knee extensions.
time frame: 10% to 100% contraction failure in a single strength training set performed until contraction failure. The strength training set is performed at a single day, 1 to 2 weeks after surgery.
description: A 0-10 numerical rating scale is used to rate knee joint pain during every repetition.
measure: Change from baseline (pre strength training) in resting knee joint pain (numerical rating scale points).
time frame: From baseline (pre strength training) to after the strength training sets. The strength training sets are performed at a single day,1 to 2 weeks after surgery.
description: A 0-10 numerical rating scale is used to rate knee joint pain at rest.
measure: Knee joint pain (in numerical rating scale points) during activities of daily living
time frame: Before the strength training sets at a single day,1 to 2 weeks after surgery.
description: Knee joint pain is rated during standing and walking, using a 0-10 numerical rating scale.
arm group label: Knee extension strength training
arm group type: Experimental
intervention type: Other
intervention name: Knee extension strength training
description: Load experiment: Four knee extensions will be performed with the operated leg at 20, 14, and 8 RM loadings each, in a randomized order. Range of knee joint motion and time under tension for each repetition will be controlled for
Failure experiment: One strength training set of knee extensions will be performed with the operated leg at 10 RM loading until contraction failure. Range of knee joint motion and time under tension for each repetition will be controlled for
arm group label: Knee extension strength 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, Copenhagen, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Thomas Bandholm
investigator title: Senior Researcher, PhD
mesh term: Arthralgia