<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/NCT02984332</url>
  </required_header>
  <id_info>
    <org_study_id>650061958</org_study_id>
    <nct_id>NCT02984332</nct_id>
  </id_info>
  <brief_title>Timecourse of Immobilization Experiment</brief_title>
  <acronym>TIME</acronym>
  <official_title>Short-term Muscle Disuse Induces a Rapid and Sustained Decline in Daily Myofibrillar Protein Synthesis Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Exeter</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Exeter</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of unilateral lower limb immobilisation over one week on muscle atrophy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to assess the effect of one week of unilateral leg immobilization on&#xD;
      quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on&#xD;
      one leg and ambulated on crutches during the immobilization period. Thirteen healthy young&#xD;
      males were recruited to undertake this study.&#xD;
&#xD;
      It is currently understood that unilateral leg immobilization will result in a reduction in&#xD;
      muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a&#xD;
      period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area&#xD;
      has shown that even short term periods of leg immobilization (i.e. &lt;1 week) will result in&#xD;
      reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall&#xD;
      et al., 2015). However we currently do not have detailed information on how muscle disuse&#xD;
      affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the&#xD;
      first week).&#xD;
&#xD;
      The stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle&#xD;
      protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the&#xD;
      immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus&#xD;
      lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore,&#xD;
      quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and&#xD;
      7 days of immobilization. To gain a mechanistic insight on the molecular changes during&#xD;
      disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess&#xD;
      the transcriptional response on genes involved in muscle protein synthesis and breakdown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">October 2019</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Muscle size</measure>
    <time_frame>Days 0, 2 and 7</time_frame>
    <description>Quadriceps muscle volume measured via MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle protein synthesis</measure>
    <time_frame>days 0-2, 2-7 and 0-7</time_frame>
    <description>The stable isotope tracer deuterium oxide will be used to assess muscle protein synthesis. In conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days which allow for the calculation of muscle protein synthesis (fractional synthesis rate) between days 0-2, 2-7 and 0-7.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Pre and post immobilization</time_frame>
    <description>Skeletal muscle one repetition maximum strength was assessed using standard gym equipment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Muscular Atrophy</condition>
  <arm_group>
    <arm_group_label>Lower limb immobilisation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will undergo 7 days of unilateral leg immobilization. Participants will wear a leg brace (Donjoy X-ACT, DJO Global, USA) on one of their legs which will fix the leg at 40 degrees of flexion for the 7 days. Participants will not be allowed to remove the brace at any stage and are prohibited from bearing weight on the immobilized leg, and will ambulate on crutches throughout the week of immobilization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lower limb immobilisation (leg brace)</intervention_name>
    <arm_group_label>Lower limb immobilisation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        BMI &gt;18 and &lt;28 no prescription medications or current illness -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        BMI &lt;18 and &gt;28 current prescription medication no history of leg injury&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sport &amp; Health Sciences</name>
      <address>
        <city>Exeter</city>
        <state>Devon</state>
        <zip>EX1 2LU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>November 6, 2019</last_update_submitted>
  <last_update_submitted_qc>November 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02984332
org study id: 650061958
nct id: NCT02984332
lead sponsor: 
has dmc: No
The effect of unilateral lower limb immobilisation over one week on muscle atrophy
This study aims to assess the effect of one week of unilateral leg immobilization on
      quadriceps muscle volume and muscle protein synthesis rates. Participants wore a leg brace on
      one leg and ambulated on crutches during the immobilization period. Thirteen healthy young
      males were recruited to undertake this study.

      It is currently understood that unilateral leg immobilization will result in a reduction in
      muscle size (Berg et al., 1996, Wall et al., 2015) and muscle protein synthesis rates after a
      period of disuse (de Boer et al., 2015, Glover et al., 2008). Recent research in this area
      has shown that even short term periods of leg immobilization (i.e. <1 week) will result in
      reductions in muscle size and muscle protein synthesis rates after the period of disuse (Wall
      et al., 2015). However we currently do not have detailed information on how muscle disuse
      affects muscle size and muscle protein synthesis over time during short term disuse (e.g. the
      first week).

      The stable isotope tracer deuterium oxide (D2O) will be applied to assess cumulative muscle
      protein synthesis between days 0-2, 2-7 and 0-7 of the immobilization period in both the
      immobilized and non immobilized legs. This will be in-conjunction with bilateral vastus
      lateralis muscle biopsies before and after 2 and 7 days of immobilization. Furthremore,
      quadriceps muscle volume was assessed via MRI scans that again occured before and after 2 and
      7 days of immobilization. To gain a mechanistic insight on the molecular changes during
      disuse a custom designed 48 well Taqman low density microarray genecard was applied to assess
      the transcriptional response on genes involved in muscle protein synthesis and breakdown.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Muscle size
time frame: Days 0, 2 and 7
description: Quadriceps muscle volume measured via MRI
measure: Muscle protein synthesis
time frame: days 0-2, 2-7 and 0-7
description: The stable isotope tracer deuterium oxide will be used to assess muscle protein synthesis. In conjunction with bilateral vastus lateralis muscle biopsies before and after 2 and 7 days which allow for the calculation of muscle protein synthesis (fractional synthesis rate) between days 0-2, 2-7 and 0-7.
measure: Muscle strength
time frame: Pre and post immobilization
description: Skeletal muscle one repetition maximum strength was assessed using standard gym equipment
arm group label: Lower limb immobilisation
arm group type: Experimental
description: All participants will undergo 7 days of unilateral leg immobilization. Participants will wear a leg brace (Donjoy X-ACT, DJO Global, USA) on one of their legs which will fix the leg at 40 degrees of flexion for the 7 days. Participants will not be allowed to remove the brace at any stage and are prohibited from bearing weight on the immobilized leg, and will ambulate on crutches throughout the week of immobilization.
intervention type: Other
intervention name: Lower limb immobilisation (leg brace)
arm group label: Lower limb immobilisation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Muscular Atrophy
sharing ipd: No