<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/NCT01712282</url>
  </required_header>
  <id_info>
    <org_study_id>30704 part 3</org_study_id>
    <nct_id>NCT01712282</nct_id>
  </id_info>
  <brief_title>Physical Activity Immediately After Acute Cerebral Ischemia 3</brief_title>
  <official_title>Physical Activity Immediately After Acute Cerebral Ischemia: Too Little or Too Much</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillerod Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillerod Hospital, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stroke is the leading cause of adult disability in Europe and United States and the second&#xD;
      leading cause of death worldwide and affects more than 10,000 Danes each year.&#xD;
&#xD;
      Studies in a late and stationary phase after stroke have shown that physical rehabilitation&#xD;
      is of great importance for survival and physical ability of these patients, however many&#xD;
      studies show that patients lie or sit next to their bed under hospitalization for more than&#xD;
      88.5 % of the daily hours. Physical activity in stroke patients has never previously been&#xD;
      measured immediately after debut of symptoms; furthermore there is no knowledge about the&#xD;
      optimal dose of physical rehabilitation for these patients.&#xD;
&#xD;
      Accelerometers, small measuring devices, are a relatively new way to measure physical&#xD;
      activity precisely, and hence it is possible to obtain an objective measure of how active&#xD;
      stroke patients are in the first week after admission. The accelerometers measure a variable&#xD;
      voltage, depending on the range and intensity of movement. They can measure movement&#xD;
      dependent of the placement of the accelerometer, for instance over the hip, arm or leg.&#xD;
      Studies confirm their reliability, even in patients with abnormal gait, such as stroke&#xD;
      patients.&#xD;
&#xD;
      Another approach of studying the effects of physical activity and rehabilitation is through&#xD;
      the examination of biomarkers. Studies have shown that biomarkers released during physical&#xD;
      activity can inhibit biomarkers released after tissue injury in the brain, as seen after&#xD;
      stroke. These brain biomarkers cause further damage and studies show that the higher the&#xD;
      levels, the higher the damage. It is therefore obvious to examine whether physical activity&#xD;
      rehabilitation can down regulate this destructive process in patients with stroke.&#xD;
&#xD;
      Clarification of the optimal dose of physical activity in stroke patients immediately after&#xD;
      debut of symptoms and examination of both the biochemical aspects of physical rehabilitation&#xD;
      as well as the optimal dose of physical rehabilitation is of great importance for many&#xD;
      patients, their relatives as well as of a great socioeconomic importance.&#xD;
&#xD;
      The purpose of the project is to investigate feasibility of treadmill training on a&#xD;
      weight-bearing treadmill in the acute phase after admission after an ischemic stroke.&#xD;
      Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and&#xD;
      whether it changes with treadmill training.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">May 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of inflammation, under, during and after treadmill training</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of biomarker level</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Correlation with time, activity counts on an accelerometer, Scandinavian Stroke Scale Score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS), Bergs Balance test, age, Body Mass Index and sex</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility</measure>
    <time_frame>up to 5 days</time_frame>
    <description>Whether it is feasible/possible to train patients on a treadmill in the acute phase after ischemic stroke; eg. whether patients are too exhausted to train twice daily, experience complications during training such as nausea or dizziness and therefore can't complete the training programme.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Acute Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>High dose training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 x 30 minutes/day on a weight-bearing treadmill</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>physical activity, 2 x 30 minutes/day</intervention_name>
    <description>weight-bearing treadmill, pulse reserve increase of 50%</description>
    <arm_group_label>High dose training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted with acute ischemic stroke&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  first stroke or only minor invalidity from previous strokes (mRS 0-2)&#xD;
&#xD;
          -  truncal stability&#xD;
&#xD;
          -  SSS score for arm and leg: 10 out of 12 points&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  symptoms attributable to other diseases than ischemic stroke&#xD;
&#xD;
          -  debut of symptoms &gt; 48 h prior to admission&#xD;
&#xD;
          -  consent not given &lt; 24 h of admission&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  isolation&#xD;
&#xD;
          -  blood sampling generally not possible&#xD;
&#xD;
          -  allergy due to accelerometer wear&#xD;
&#xD;
          -  ulcers or other skin diseases in the area of accelerometer placement&#xD;
&#xD;
          -  unstable cardiologic condition (AMI etc.)&#xD;
&#xD;
          -  acute high and sustained resting systolic blood pressure where treatment is necessary&#xD;
&#xD;
          -  acute heart rhythm disorder where treatment is necessary&#xD;
&#xD;
          -  unable to cooperate&#xD;
&#xD;
          -  significant orthopedic conditions (fractures etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Anna M Strømmen, MD</last_name>
    <phone>+4548297353</phone>
    <email>anna.maria.stroemmen@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillerød Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Maria Strømmen, MD</last_name>
      <phone>+4548297353</phone>
      <email>anna.maria.stroemmen@regionh.dk</email>
    </contact>
    <investigator>
      <last_name>Anna Maria Strømmen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>March 13, 2013</last_update_submitted>
  <last_update_submitted_qc>March 13, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 14, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillerod Hospital, Denmark</investigator_affiliation>
    <investigator_full_name>Anna Maria Strømmen</investigator_full_name>
    <investigator_title>clinical assistant</investigator_title>
  </responsible_party>
  <keyword>Physical Activity</keyword>
  <keyword>Accelerometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</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/NCT01712282
org study id: 30704 part 3
nct id: NCT01712282
lead sponsor: 
has dmc: No
Stroke is the leading cause of adult disability in Europe and United States and the second
      leading cause of death worldwide and affects more than 10,000 Danes each year.

      Studies in a late and stationary phase after stroke have shown that physical rehabilitation
      is of great importance for survival and physical ability of these patients, however many
      studies show that patients lie or sit next to their bed under hospitalization for more than
      88.5 % of the daily hours. Physical activity in stroke patients has never previously been
      measured immediately after debut of symptoms; furthermore there is no knowledge about the
      optimal dose of physical rehabilitation for these patients.

      Accelerometers, small measuring devices, are a relatively new way to measure physical
      activity precisely, and hence it is possible to obtain an objective measure of how active
      stroke patients are in the first week after admission. The accelerometers measure a variable
      voltage, depending on the range and intensity of movement. They can measure movement
      dependent of the placement of the accelerometer, for instance over the hip, arm or leg.
      Studies confirm their reliability, even in patients with abnormal gait, such as stroke
      patients.

      Another approach of studying the effects of physical activity and rehabilitation is through
      the examination of biomarkers. Studies have shown that biomarkers released during physical
      activity can inhibit biomarkers released after tissue injury in the brain, as seen after
      stroke. These brain biomarkers cause further damage and studies show that the higher the
      levels, the higher the damage. It is therefore obvious to examine whether physical activity
      rehabilitation can down regulate this destructive process in patients with stroke.

      Clarification of the optimal dose of physical activity in stroke patients immediately after
      debut of symptoms and examination of both the biochemical aspects of physical rehabilitation
      as well as the optimal dose of physical rehabilitation is of great importance for many
      patients, their relatives as well as of a great socioeconomic importance.

      The purpose of the project is to investigate feasibility of treadmill training on a
      weight-bearing treadmill in the acute phase after admission after an ischemic stroke.
      Furthermore we wish to investigate the acute inflammatory response after ischemic stroke and
      whether it changes with treadmill training.
allocation: Non-Randomized
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Level of inflammation, under, during and after treadmill training
time frame: up to 5 days
description: Biomarker concentration: Interleukin (IL)-6, IL-1beta, Tumor Necrosis Factor(TNF)-alpha, C-Reactive Protein (CRP), IL-1ra, IL-10, fasting-insulin, fasting-glucose
measure: Correlation of biomarker level
time frame: up to 5 days
description: Correlation with time, activity counts on an accelerometer, Scandinavian Stroke Scale Score (SSS), National Institutes of Health Stroke Scale score (NIHSS), Glasgow Coma Scale (GCS), Barthels Index-100 (BI), 10 Meters Walking Test (10MWT), modified Rankin Scale (mRS), Assessment of Motor and Process Skills (AMPS), Bergs Balance test, age, Body Mass Index and sex
measure: Feasibility
time frame: up to 5 days
description: Whether it is feasible/possible to train patients on a treadmill in the acute phase after ischemic stroke; eg. whether patients are too exhausted to train twice daily, experience complications during training such as nausea or dizziness and therefore can't complete the training programme.
arm group label: High dose training
arm group type: Experimental
description: 2 x 30 minutes/day on a weight-bearing treadmill
intervention type: Behavioral
intervention name: physical activity, 2 x 30 minutes/day
description: weight-bearing treadmill, pulse reserve increase of 50%
arm group label: High dose training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anna M Strømmen, MD
phone: +4548297353
email: anna.maria.stroemmen@regionh.dk
facility: 
status: Recruiting
contact: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hillerod Hospital, Denmark
investigator full name: Anna Maria Strømmen
investigator title: clinical assistant
mesh term: Ischemic Stroke
mesh term: Brain Ischemia
mesh term: Cerebral Infarction
mesh term: Ischemia