<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/NCT01712724</url>
  </required_header>
  <id_info>
    <org_study_id>OSN1207-000144</org_study_id>
    <secondary_id>OSN1207-000144</secondary_id>
    <nct_id>NCT01712724</nct_id>
  </id_info>
  <brief_title>Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke</brief_title>
  <acronym>TRI-RAvA</acronym>
  <official_title>Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart and Stroke Foundation of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ontario Stroke Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both aerobic training (AT) and resistance/strength training (RT) have the potential to&#xD;
      improve recovery after stroke. Research conducted in chronic disease and healthy populations&#xD;
      suggest that AT and RT &quot;combination therapy&quot; may produce synergistic and superior effects&#xD;
      along cognition and mobility domains, when compared to AT alone. However, the effects of a&#xD;
      combined training approach (AT+RT) compared to AT alone has not been investigated in people&#xD;
      post-stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients referred to Toronto Rehabilitation Institute's Risk Factor Modification and Exercise&#xD;
      Program following Stroke (TRI-REPS) will be randomized to either AT+RT or AT alone. Mobility&#xD;
      (6 minute walk test), and cognition (Vascular Cognitive Impairment Harmonization Standards)&#xD;
      will be measured pre- post 6 months of exercise. Secondary measures will include body&#xD;
      composition, and biochemical changes. This project will help to determine an exercise&#xD;
      treatment strategy that will guide best practice guidelines aimed at promoting mobility and&#xD;
      brain health in people post-stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive function</measure>
    <time_frame>1 year</time_frame>
    <description>Vascular Cognitive Impairment Harmonization Standards</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body Composition</measure>
    <time_frame>1 year</time_frame>
    <description>Fat free mass will be measured by dual energy x-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical Changes (blood samples)</measure>
    <time_frame>1 year</time_frame>
    <description>brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Mobility</measure>
    <time_frame>1 year</time_frame>
    <description>Six minute walk distance</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cerebrovascular Accident</condition>
  <arm_group>
    <arm_group_label>Aerobic Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Walking, elliptical, stationary recumbent or upright cycling will be the modes of AT prescribed depending on individual ability and access to equipment when away from the Centre. Treadmill or overground walking will be considered for those who can sustain high enough speeds and durations to achieve aerobic benefit. Cycle ergometer exercise (upright or recumbent) will be prescribed to patients in addition to walking when stroke-related deficits preclude a sufficient walking speed. The AT group will complete AT 5 d∙wk-1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combined Resistance and Aerobic Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The AT+RT group will complete AT 3 d∙wk-1 + RT 2 d∙wk-1.The RT exercises will be task specific, incorporating muscle actions that are performed during daily activities. Resistance will be provided by hand-held dumbbells, exercise bands (wrist/ankle attachments), or patients' body weight. A weight load equivalent to 50-60% of 1 repetition maximum will be prescribed on the non-affected limb. On the hemiparetic limb ≥50% of 1 repetition maximum and/or a resistance rated as 13-14 on the Rating of Perceived Exertion scale on the last repetition of the set will be prescribed</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>combined resistance and aerobic training</intervention_name>
    <description>For the group randomized to AT+RT, Patients will gradually be progressed from 1-2 sets and then from 10-15 repetitions and then increase resistance by 1.6-5 kg or increase the exercise band level and then reduced repetitions to 10 and repeated this process.</description>
    <arm_group_label>Aerobic Training</arm_group_label>
    <arm_group_label>Combined Resistance and Aerobic Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of stroke (ischemic or hemorrhagic)&#xD;
&#xD;
          -  Ability to walk at least 100 m independently with or without an assistive&#xD;
&#xD;
          -  device with no severe limitations due to pain&#xD;
&#xD;
          -  Living in the community at least 3 months post stroke (no upper limit)&#xD;
&#xD;
          -  Stroke-related motor impairment score of 3-6 on the Chedoke-McMaster Stroke&#xD;
&#xD;
          -  Assessment scale of the leg and/or foot&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable angina or orthostatic blood pressure decrease of &gt; 20 mmHg&#xD;
&#xD;
          -  Resting hypertension (SBP &gt; 160 mm Hg or DBP &gt; 100 mm Hg)&#xD;
&#xD;
          -  Diabetes related or other eye/vision complications (severe proliferative retinopathy)&#xD;
&#xD;
          -  Cardiovascular morbidities which would limit exercise tolerance (e.g. heart failure,&#xD;
             hypertrophic cardiomyopathy, horizontal or downsloping ST-segment depression &gt; 2 mm,&#xD;
             symptomatic aortic stenosis, complex arrhythmias)&#xD;
&#xD;
          -  Musculoskeletal impairments which would preclude safe participation in exercise&#xD;
&#xD;
          -  Cognitive and/or behavioral issues that would significantly limit participation in&#xD;
             exercise testing and training, prior unrelated neurological disorders or psychiatric&#xD;
             illness&#xD;
&#xD;
          -  Severe communicative aphasia or comprehensive aphasia (as noted in clinical reports)&#xD;
&#xD;
          -  Patients with anxiety disorder, claustrophobia, or pacemaker implantation will be&#xD;
             excluded from brain imaging and perfusion measures&#xD;
&#xD;
          -  Exposure to a similar or identical neuropsychological battery within &lt;6 months&#xD;
&#xD;
          -  Currently smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Toronto Rehabilitation Institute</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5R 1G7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>October 31, 2016</last_update_submitted>
  <last_update_submitted_qc>October 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exercise therapy</keyword>
  <keyword>rehabilitation</keyword>
  <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/NCT01712724
org study id: OSN1207-000144
secondary id: OSN1207-000144
nct id: NCT01712724
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Both aerobic training (AT) and resistance/strength training (RT) have the potential to
      improve recovery after stroke. Research conducted in chronic disease and healthy populations
      suggest that AT and RT "combination therapy" may produce synergistic and superior effects
      along cognition and mobility domains, when compared to AT alone. However, the effects of a
      combined training approach (AT+RT) compared to AT alone has not been investigated in people
      post-stroke.
Patients referred to Toronto Rehabilitation Institute's Risk Factor Modification and Exercise
      Program following Stroke (TRI-REPS) will be randomized to either AT+RT or AT alone. Mobility
      (6 minute walk test), and cognition (Vascular Cognitive Impairment Harmonization Standards)
      will be measured pre- post 6 months of exercise. Secondary measures will include body
      composition, and biochemical changes. This project will help to determine an exercise
      treatment strategy that will guide best practice guidelines aimed at promoting mobility and
      brain health in people post-stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Cognitive function
time frame: 1 year
description: Vascular Cognitive Impairment Harmonization Standards
measure: Body Composition
time frame: 1 year
description: Fat free mass will be measured by dual energy x-ray absorptiometry
measure: Biochemical Changes (blood samples)
time frame: 1 year
description: brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein
measure: Functional Mobility
time frame: 1 year
description: Six minute walk distance
arm group label: Aerobic Training
arm group type: Active Comparator
description: Walking, elliptical, stationary recumbent or upright cycling will be the modes of AT prescribed depending on individual ability and access to equipment when away from the Centre. Treadmill or overground walking will be considered for those who can sustain high enough speeds and durations to achieve aerobic benefit. Cycle ergometer exercise (upright or recumbent) will be prescribed to patients in addition to walking when stroke-related deficits preclude a sufficient walking speed. The AT group will complete AT 5 d∙wk-1.
arm group label: Combined Resistance and Aerobic Training
arm group type: Experimental
description: The AT+RT group will complete AT 3 d∙wk-1 + RT 2 d∙wk-1.The RT exercises will be task specific, incorporating muscle actions that are performed during daily activities. Resistance will be provided by hand-held dumbbells, exercise bands (wrist/ankle attachments), or patients' body weight. A weight load equivalent to 50-60% of 1 repetition maximum will be prescribed on the non-affected limb. On the hemiparetic limb ≥50% of 1 repetition maximum and/or a resistance rated as 13-14 on the Rating of Perceived Exertion scale on the last repetition of the set will be prescribed
intervention type: Other
intervention name: combined resistance and aerobic training
description: For the group randomized to AT+RT, Patients will gradually be progressed from 1-2 sets and then from 10-15 repetitions and then increase resistance by 1.6-5 kg or increase the exercise band level and then reduced repetitions to 10 and repeated this process.
arm group label: Aerobic Training
arm group label: Combined Resistance and Aerobic Training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Stroke