<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/NCT01674790</url>
  </required_header>
  <id_info>
    <org_study_id>Priming Study</org_study_id>
    <nct_id>NCT01674790</nct_id>
  </id_info>
  <brief_title>Combined Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke</brief_title>
  <official_title>Exploring Potential Synergistic Effects of Aerobic Exercise and Cognitive Training on Cognition After Stroke.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marilyn MacKay-Lyons</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Nova Scotia Health Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nova Scotia Health Authority</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the 'Exploring potential synergistic effects of aerobic exercise and&#xD;
      cognitive training on cognition after stroke' pilot trial is to investigate the combined&#xD;
      effects of aerobic and cognitive training on cognition after stroke. This is to lay the&#xD;
      groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months&#xD;
      post-stroke will be randomly assigned into one of four following treatment groups: (i)&#xD;
      aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic&#xD;
      exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of&#xD;
      motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please&#xD;
      see detailed description below). We hypothesize that the combination of aerobic exercise and&#xD;
      cognitive training will be more effective in improving cognition after stroke than either&#xD;
      treatment on its own.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aerobic exercise: Body weight support (BWS) treadmill exercise at moderately high intensity&#xD;
      (60-70% of heart rate reserve) using 15-30% BWS. An additional 6-10 min will be needed for&#xD;
      warm-up and cool-down. Heart rate will be continuously monitored, and blood pressure and&#xD;
      rating of perceived exertion (RPE) will be measured periodically.&#xD;
&#xD;
      Cognitive training: Computerized dual n-back training program that involves a working memory&#xD;
      task, the difficulty of which adapts to the individual participant's performance.&#xD;
&#xD;
      ROM exercise: Non-aerobic passive and active movement of upper and lower extremity joints&#xD;
      performed with the subject lying on a plinth. RPE will be recorded every 5 minutes to ensure&#xD;
      intensity remains low. Mental activities: Unstructured mental activity: such as listening to&#xD;
      light novels on tape, which will be selected by the subject from a pre-determined list.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 13, 2013</start_date>
  <completion_date type="Actual">June 16, 2017</completion_date>
  <primary_completion_date type="Actual">June 16, 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flanker Test</measure>
    <time_frame>10 weeks</time_frame>
    <description>Flanker Test is a computerized test of selective attention and reaction time that involves a motor response. The participant needs to focus and identify an item presented on a screen while ignoring task-irrelevant distractors. Performance on this test has been shown to improve with exercise.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Raven's matrices test</measure>
    <time_frame>10 weeks</time_frame>
    <description>A measure of non-verbal reasoning ability and fluid intelligence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sternberg digit memory task</measure>
    <time_frame>10 weeks</time_frame>
    <description>A measure of visual working memory wherein the subject is shown a set of n digits for study. After a short delay, a digit is shown and the subject is asked to recall whether that item was in the previously viewed set</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak oxygen consumption</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity Scale</measure>
    <time_frame>10 weeks</time_frame>
    <description>Brief 9-item questionnaire designed to assess patient fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Failures Questionnaire</measure>
    <time_frame>10 weeks</time_frame>
    <description>A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expression of BDNF and IGF-1 in peripheral blood samples</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>AEROBIC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>COGNITIVE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AEROBIC + COGNITIVE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic training</intervention_name>
    <description>One 20-min session of body weight support treadmill training at moderate to high intensity (60-70% heart rate reserve) 5 days/week for 6-weeks.</description>
    <arm_group_label>AEROBIC + COGNITIVE group</arm_group_label>
    <arm_group_label>AEROBIC group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive training</intervention_name>
    <description>One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.</description>
    <arm_group_label>AEROBIC + COGNITIVE group</arm_group_label>
    <arm_group_label>COGNITIVE group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Range of motion exercise</intervention_name>
    <description>One 20-min session of range of motion exercise (non-aerobic passive and active movement of upper and lower extremity) 5 days/week for 6-weeks.</description>
    <arm_group_label>AEROBIC group</arm_group_label>
    <arm_group_label>COGNITIVE group</arm_group_label>
    <arm_group_label>CONTROL group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Unstructured mental activity</intervention_name>
    <description>One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.</description>
    <arm_group_label>CONTROL group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Diagnosis of ischemic or hemorrhagic stroke &gt;6months ago&#xD;
&#xD;
          -  Be able to perform a two-step command&#xD;
&#xD;
          -  Be able to walk ≥10m with/without aid&#xD;
&#xD;
          -  Live within a 75km radius of the QE II&#xD;
&#xD;
          -  Pass a cardiology screen for safe participants in exercise training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have moderate or severe receptive aphasia&#xD;
&#xD;
          -  Have terminal illness, life-threatening co-morbidity or concomitant neurological or&#xD;
             psychiatric illness&#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_official>
    <last_name>Marilyn MacKay-Lyons, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Nova Scotia Rehabilitation Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 4R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>School of Physiotherapy, Dalhousie University</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 4R2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>March 21, 2018</last_update_submitted>
  <last_update_submitted_qc>March 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nova Scotia Health Authority</investigator_affiliation>
    <investigator_full_name>Marilyn MacKay-Lyons</investigator_full_name>
    <investigator_title>Affiliated Scientist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stroke</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/NCT01674790
org study id: Priming Study
nct id: NCT01674790
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The objective of the 'Exploring potential synergistic effects of aerobic exercise and
      cognitive training on cognition after stroke' pilot trial is to investigate the combined
      effects of aerobic and cognitive training on cognition after stroke. This is to lay the
      groundwork for a larger RCT on the same topic. Twenty patients greater than 6 months
      post-stroke will be randomly assigned into one of four following treatment groups: (i)
      aerobic training (AEROBIC group), (ii) cognitive training (COGNITIVE group), (iii) aerobic
      exercise plus cognitive training (AEROBIC+COGNITIVE group); and (iv) non-aerobic range of
      motion (ROM) and unstructured mental activity (CONTROL group) (for group descriptions, please
      see detailed description below). We hypothesize that the combination of aerobic exercise and
      cognitive training will be more effective in improving cognition after stroke than either
      treatment on its own.
Aerobic exercise: Body weight support (BWS) treadmill exercise at moderately high intensity
      (60-70% of heart rate reserve) using 15-30% BWS. An additional 6-10 min will be needed for
      warm-up and cool-down. Heart rate will be continuously monitored, and blood pressure and
      rating of perceived exertion (RPE) will be measured periodically.

      Cognitive training: Computerized dual n-back training program that involves a working memory
      task, the difficulty of which adapts to the individual participant's performance.

      ROM exercise: Non-aerobic passive and active movement of upper and lower extremity joints
      performed with the subject lying on a plinth. RPE will be recorded every 5 minutes to ensure
      intensity remains low. Mental activities: Unstructured mental activity: such as listening to
      light novels on tape, which will be selected by the subject from a pre-determined list.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Flanker Test
time frame: 10 weeks
description: Flanker Test is a computerized test of selective attention and reaction time that involves a motor response. The participant needs to focus and identify an item presented on a screen while ignoring task-irrelevant distractors. Performance on this test has been shown to improve with exercise.
measure: Raven's matrices test
time frame: 10 weeks
description: A measure of non-verbal reasoning ability and fluid intelligence.
measure: Sternberg digit memory task
time frame: 10 weeks
description: A measure of visual working memory wherein the subject is shown a set of n digits for study. After a short delay, a digit is shown and the subject is asked to recall whether that item was in the previously viewed set
measure: Peak oxygen consumption
time frame: 10 weeks
measure: Fatigue Severity Scale
time frame: 10 weeks
description: Brief 9-item questionnaire designed to assess patient fatigue
measure: Cognitive Failures Questionnaire
time frame: 10 weeks
description: A measure of self-reported deficits in completing simple everyday tasks due to failures in attention, memory, perception, and motor function.
measure: Montreal Cognitive Assessment
time frame: 10 weeks
measure: Expression of BDNF and IGF-1 in peripheral blood samples
time frame: 10 weeks
arm group label: AEROBIC group
arm group type: Experimental
description: 6-week program of one 20-min session of aerobic training and one 20-min session of ROM exercise 5 days/week.
arm group label: COGNITIVE group
arm group type: Experimental
description: 6-week program of one 20-min session of cognitive training and one 20-min session of ROM exercise 5 days/week.
arm group label: AEROBIC + COGNITIVE group
arm group type: Experimental
description: 6-week program of one 20-min session of aerobic training and one 20-min session of cognitive training 5 days/week.
arm group label: CONTROL group
arm group type: Experimental
description: 6-week program of one 20-min session of ROM exercise and one 20-min session of unstructured mental activity 5 days/week.
intervention type: Behavioral
intervention name: Aerobic training
description: One 20-min session of body weight support treadmill training at moderate to high intensity (60-70% heart rate reserve) 5 days/week for 6-weeks.
arm group label: AEROBIC + COGNITIVE group
arm group label: AEROBIC group
intervention type: Behavioral
intervention name: Cognitive training
description: One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
arm group label: AEROBIC + COGNITIVE group
arm group label: COGNITIVE group
intervention type: Behavioral
intervention name: Range of motion exercise
description: One 20-min session of range of motion exercise (non-aerobic passive and active movement of upper and lower extremity) 5 days/week for 6-weeks.
arm group label: AEROBIC group
arm group label: COGNITIVE group
arm group label: CONTROL group
intervention type: Behavioral
intervention name: Unstructured mental activity
description: One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.
arm group label: CONTROL group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marilyn MacKay-Lyons, PhD
role: Principal Investigator
affiliation: Dalhousie University
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Nova Scotia Health Authority
investigator full name: Marilyn MacKay-Lyons
investigator title: Affiliated Scientist
mesh term: Stroke