<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/NCT02980796</url>
  </required_header>
  <id_info>
    <org_study_id>H16-01945</org_study_id>
    <nct_id>NCT02980796</nct_id>
  </id_info>
  <brief_title>The Influence of Exercise on Neuroplasticity and Motor Learning After Stroke</brief_title>
  <acronym>EX-ML3</acronym>
  <official_title>The Influence of Acute Bouts of Aerobic Exercise on Neuroplasticity and Motor Learning After Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants will complete 11 sessions. These include screening, 5 sessions where exercise or&#xD;
      rest (according to group assignment) are paired with practice of a motor task, MRI and&#xD;
      Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to&#xD;
      assess neuroplasticity (ability for the brain to reorganize and create new connections).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will complete baseline sessions: 1) sub-maximal exercise test to ensure safe&#xD;
      participation in aerobic exercise (testing session [s] 1); and 2) magnetic resonance imaging&#xD;
      (MRI) to assess brain structure and function, and 3) clinical assessments of motor function&#xD;
      and activity. The MRI and clinical tests will be completed on s2. Between the exercise test&#xD;
      and MRI sessions individuals will wear accelerometers for 3 days to index usual activity&#xD;
      levels. A custom computer program will then assign participants quasi-randomly to either the&#xD;
      rest or exercise groups stratified on age, sex, and baseline motor function. Cortical&#xD;
      excitability will be assessed before and after either a single session of priming aerobic&#xD;
      exercise, or rest, by group (s3). Next, priming exercise will be paired with skilled motor&#xD;
      practice for 5 sessions (s4-8). Practice sessions will be separated by 48 hours. Importantly&#xD;
      motor learning will be assessed via delayed, no-exercise retention tests 24-hours (s9) and&#xD;
      30-days (s11) after the last practice session. Activity levels (3 day accelerometry), TMS and&#xD;
      MRI measures will be re-assessed after the second retention test (s10).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change response time during a novel motor task.</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Serial targeting task</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wolf Motor Function Task Rate</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Standardized test of arm motor function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transcallosal Inhibition</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Ipsilateral silent period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arm Use Ratio</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Accelerometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional magnetic resonance imaging (fMRI)</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Resting state fMRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural magnetic resonance imaging - myelin</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Myelin water fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Structural magnetic resonance imaging - diffusion</measure>
    <time_frame>Baseline, After Intervention (2 weeks), 30-day follow-up</time_frame>
    <description>Diffusion weighted fractional anisotrophy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Stroke</condition>
  <condition>Exercise</condition>
  <condition>Rest</condition>
  <arm_group>
    <arm_group_label>Exercise + practice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rest + practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Each experimental day participants will complete an acute bout of exercise on a recumbent bike.</description>
    <arm_group_label>Exercise + practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Practice</intervention_name>
    <description>Each experimental day participants will complete a session of skilled motor practice.</description>
    <arm_group_label>Exercise + practice</arm_group_label>
    <arm_group_label>Rest + practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 40 - 85&#xD;
&#xD;
          -  Had a stroke at least 12 months ago&#xD;
&#xD;
          -  OR are a healthy adult who does not have a history of neurodegenerative disorders&#xD;
&#xD;
          -  Have the ability to understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to brain stimulation (such as a history of seizure or epilepsy)&#xD;
&#xD;
          -  Contraindication to MRI (such as a pacemaker, metal in the eyes / brain or fear of&#xD;
             enclosed spaces)&#xD;
&#xD;
          -  Neurodegenerative disorder ( such as Parkinson disease, Alzheimers disease or Multiple&#xD;
             Sclerosis)&#xD;
&#xD;
          -  Contraindications to exercise&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lara Boyd, Pt, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Univeristy of British Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asha Toner, BSc</last_name>
    <phone>604-828-6303</phone>
    <email>asha.toner@ubc.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jason Neva, PhD</last_name>
    <phone>604-827-3369</phone>
    <email>jason.neva@ubc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of British Columbia</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 2B5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asha Toner, BSc</last_name>
      <phone>604-828-6303</phone>
      <email>asha.toner@ubc.ca</email>
    </contact>
    <contact_backup>
      <last_name>Tamara Koren, MSc</last_name>
      <phone>604-822-6886</phone>
      <email>tamara.koren@ubc.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>August 11, 2017</last_update_submitted>
  <last_update_submitted_qc>August 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lara Boyd</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Brain</keyword>
  <keyword>MRI</keyword>
  <keyword>Exercise</keyword>
  <keyword>Rehabilitation</keyword>
  <keyword>TMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02980796
org study id: H16-01945
nct id: NCT02980796
lead sponsor: 
has dmc: No
Participants will complete 11 sessions. These include screening, 5 sessions where exercise or
      rest (according to group assignment) are paired with practice of a motor task, MRI and
      Transcranial Magnetic Stimulation (TMS) before and after the intervention will be used to
      assess neuroplasticity (ability for the brain to reorganize and create new connections).
All participants will complete baseline sessions: 1) sub-maximal exercise test to ensure safe
      participation in aerobic exercise (testing session [s] 1); and 2) magnetic resonance imaging
      (MRI) to assess brain structure and function, and 3) clinical assessments of motor function
      and activity. The MRI and clinical tests will be completed on s2. Between the exercise test
      and MRI sessions individuals will wear accelerometers for 3 days to index usual activity
      levels. A custom computer program will then assign participants quasi-randomly to either the
      rest or exercise groups stratified on age, sex, and baseline motor function. Cortical
      excitability will be assessed before and after either a single session of priming aerobic
      exercise, or rest, by group (s3). Next, priming exercise will be paired with skilled motor
      practice for 5 sessions (s4-8). Practice sessions will be separated by 48 hours. Importantly
      motor learning will be assessed via delayed, no-exercise retention tests 24-hours (s9) and
      30-days (s11) after the last practice session. Activity levels (3 day accelerometry), TMS and
      MRI measures will be re-assessed after the second retention test (s10).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Change response time during a novel motor task.
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Serial targeting task
measure: Wolf Motor Function Task Rate
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Standardized test of arm motor function
measure: Transcallosal Inhibition
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Ipsilateral silent period
measure: Arm Use Ratio
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Accelerometry
measure: Functional magnetic resonance imaging (fMRI)
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Resting state fMRI
measure: Structural magnetic resonance imaging - myelin
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Myelin water fraction
measure: Structural magnetic resonance imaging - diffusion
time frame: Baseline, After Intervention (2 weeks), 30-day follow-up
description: Diffusion weighted fractional anisotrophy
arm group label: Exercise + practice
arm group type: Experimental
description: Individuals will complete 20 minutes of exercise on a recumbent bicycle before practicing a novel motor task.
arm group label: Rest + practice
arm group type: Active Comparator
description: Individuals will rest for 20 minutes before practicing a novel motor task. Attention will be controlled during this time.
intervention type: Behavioral
intervention name: Exercise
description: Each experimental day participants will complete an acute bout of exercise on a recumbent bike.
arm group label: Exercise + practice
intervention type: Behavioral
intervention name: Practice
description: Each experimental day participants will complete a session of skilled motor practice.
arm group label: Exercise + practice
arm group label: Rest + practice
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lara Boyd, Pt, PhD
role: Principal Investigator
affiliation: Univeristy of British Columbia
last name: Asha Toner, BSc
phone: 604-828-6303
email: asha.toner@ubc.ca
last name: Jason Neva, PhD
phone: 604-827-3369
email: jason.neva@ubc.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lara Boyd
investigator title: Professor
mesh term: Stroke
sharing ipd: Undecided