<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/NCT03230253</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-F(II)-20170040</org_study_id>
    <nct_id>NCT03230253</nct_id>
  </id_info>
  <brief_title>Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline</brief_title>
  <official_title>Effects and Mechanism of Two Hybrid Exercise-cognitive Trainings in Mild Ischemic Stroke With Cognitive Decline: fMRI for Brain Plasticity, and Biomarker and Behavioral Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain&#xD;
      plasticity, physiological biomarkers and behavioral outcomes, including cognitive and&#xD;
      physical functions, from pre- to post-training; (2) understand the neural mechanisms of&#xD;
      cognitive recovery following two hybrid interventions using the functional magnetic resonance&#xD;
      imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to&#xD;
      identify the correlations between brain activity, biomarkers and behavioral measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cognitive decline after stroke is highly associated with functional disability. Empirical&#xD;
      evidence shows that exercise combined cognitive training may induce neuroplastic changes that&#xD;
      modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive&#xD;
      trainings can facilitate cortical activity and physiological outcome measures and further&#xD;
      influence on the cognitive function after stroke. We aim to investigate the effects of two&#xD;
      hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and&#xD;
      behavioral outcomes in stroke survivors with cognitive decline. This study is a single-blind&#xD;
      randomized controlled trial. A target sample size of 75 participants will be recruited.&#xD;
      Stroke survivors with mild cognitive decline will be stratified by Mini-Mental State&#xD;
      Examination scores and then randomized 1:1:1 to sequential exercise-cognitive training,&#xD;
      dual-task exercise-cognitive training or control groups. All groups will undergo trainings 60&#xD;
      min/day, 3 days/week, for a total of 12 weeks. The primary outcome is the resting-state&#xD;
      functional connectivity and neural activation in the frontal, parietal and occipital lobes in&#xD;
      functional magnetic resonance imaging. Secondary outcomes include physiological biomarkers,&#xD;
      cognitive functions, physical function, daily functions and quality of life.&#xD;
&#xD;
      This study may differentiate the effects of two hybridized trainings on cognitive function&#xD;
      and health-related conditions and detect appropriate neurological and physiological indices&#xD;
      to predict training effects. This study capitalizes on the groundwork for non-pharmacological&#xD;
      intervention of cognitive decline after stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 19, 2018</start_date>
  <completion_date type="Actual">July 31, 2020</completion_date>
  <primary_completion_date type="Actual">July 3, 2020</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>fMRI (change is being assessed)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).</time_frame>
    <description>Resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum BDNF level</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months)</time_frame>
    <description>Up-regulation of neurotrophic and vascular growth factors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antioxidative marker</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months)]</time_frame>
    <description>Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose indicator</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months)</time_frame>
    <description>HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma lipid level</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months)</time_frame>
    <description>The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montreal Cognitive Assessment (MoCA)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Memory Scale - Third Edition (WMS-III)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The WAIS-III is developed to measure an individual's intelligence level. It includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Useful Field of View (UFOV)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Color-Word test</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dual-task test</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The dual-task test evaluates the ability to shift attention between one task and another. Participants will perform the box and block test (BBT) while doing secondary cognitive tasks while sitting. Participants will perform BBT by affected and less affected hand.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time up and go test (TUG)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six-minute walk test (6MWT)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaires (IPAQ)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The IPAQ is an international measure of health-related physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fugl-Meyer Assessment (FMA)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The 33-item upper limb subscale of the FMA will be used to assess motor impairments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rivermead Mobility Index (RMI)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The RMI evaluates the participant's bed mobility, postural transfers and walking ability. It contains a 15-item scale which includes 14 questions and one direct observation, with a total of score of 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mobility level</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Independence Measure (FIM)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lawton Instrumental Activities of Daily Living Scale (Lawton LADL)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The Lawton IADL scale assesses independent living skills, such as shopping or managing finances.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke Impact Scale (SIS)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden Scale (CB scale)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>B scale evaluates the burden of the primary caregiver of the participants. Lessening the burden of caregivers after the intervention may significantly improve the quality of life for patients with stroke and their family.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol-5D questionnaire (EQ-5D)</measure>
    <time_frame>Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)</time_frame>
    <description>The quality of life will be assessed by the EQ-5D questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Stroke Patients With Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Sequential training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise training for 30 minutes followed by 30 minutes of cognitive-based intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual training group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercise training simultaneously combined cognitive-based intervention for 60 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control training group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>non-aerobic exercise (e.g., stretch, range of motion exercise...) and unstructured cognitive rehabilitation programs (e.g., reading newspapers, playing board games...) for 60 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sequential training</intervention_name>
    <description>The participant will cycle on a stationary bike for 30 minutes, which includes a 3-min warm-up phase followed by the aerobic training components (25 minutes), then a 2-min cool-down phase. The target heart rate during the aerobic training phase will be 40 to 70% of maximal heart rate (HRmax). After cycling, the participant will engage in a 30-minute of computer-based cognitive training program using BrainHQ (Posit Science Inc., San Francisco, CA, USA). The following are the areas of training: visuospatial processing, attention, memory, language, and logical thinking.</description>
    <arm_group_label>Sequential training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dual training</intervention_name>
    <description>The dual-task training group will cycling concurrently with the computer-based cognitive training. The training principle of cycling and cognitive training is similar to the SEQ group; however, the training intensity will be adjusted according to each participant's ability.</description>
    <arm_group_label>Dual training group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control training</intervention_name>
    <description>The control participants will receive 60 minutes of health-related rehabilitation programs which involves non-aerobic physical exercise (e.g., muscle stretching, range of motion exercises, relaxation techniques) and unstructured cognitive related rehabilitation programs (e.g., watch health-related videos or read newspapers or magazines and then answer the content-related questions raised by the therapist).</description>
    <arm_group_label>Control training group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Stroke occurring at least 6 months prior to enrollment&#xD;
&#xD;
          2. Age range from 20 to 80 years&#xD;
&#xD;
          3. MMSE score &lt; 28 or MoCA&lt;25&#xD;
&#xD;
          4. Able to follow the study instruction&#xD;
&#xD;
          5. Adequate cardiopulmonary function to perform aerobic exercise&#xD;
&#xD;
          6. Able to walk with or without assistive devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unstable medical history (e.g., recent myocardial infarction) that might limit&#xD;
             participation&#xD;
&#xD;
          2. Concomitant with other neurological disorders (e.g., Parkinson's disease, amyotrophic&#xD;
             lateral sclerosis, multiple sclerosis)&#xD;
&#xD;
          3. Current participation in another interventional trial&#xD;
&#xD;
          4. Any contraindication to MRI (metallic implants, claustrophobia, seizure, pacemakers,&#xD;
             et al)&#xD;
&#xD;
          5. Pregnant woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-yi Wu, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Municipal Siaogang Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>812</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</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>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03230253
org study id: KMUHIRB-F(II)-20170040
nct id: NCT03230253
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purposes are to: (1) examine and compare the effects of two hybrid interventions on brain
      plasticity, physiological biomarkers and behavioral outcomes, including cognitive and
      physical functions, from pre- to post-training; (2) understand the neural mechanisms of
      cognitive recovery following two hybrid interventions using the functional magnetic resonance
      imaging (fMRI); (3) examine the long-term benefits of the two hybrid therapies; (4) to
      identify the correlations between brain activity, biomarkers and behavioral measures.
Cognitive decline after stroke is highly associated with functional disability. Empirical
      evidence shows that exercise combined cognitive training may induce neuroplastic changes that
      modulate cognitive function. However, it is unclear whether hybridized exercise-cognitive
      trainings can facilitate cortical activity and physiological outcome measures and further
      influence on the cognitive function after stroke. We aim to investigate the effects of two
      hybridized exercise-cognitive trainings on brain plasticity, physiological biomarkers and
      behavioral outcomes in stroke survivors with cognitive decline. This study is a single-blind
      randomized controlled trial. A target sample size of 75 participants will be recruited.
      Stroke survivors with mild cognitive decline will be stratified by Mini-Mental State
      Examination scores and then randomized 1:1:1 to sequential exercise-cognitive training,
      dual-task exercise-cognitive training or control groups. All groups will undergo trainings 60
      min/day, 3 days/week, for a total of 12 weeks. The primary outcome is the resting-state
      functional connectivity and neural activation in the frontal, parietal and occipital lobes in
      functional magnetic resonance imaging. Secondary outcomes include physiological biomarkers,
      cognitive functions, physical function, daily functions and quality of life.

      This study may differentiate the effects of two hybridized trainings on cognitive function
      and health-related conditions and detect appropriate neurological and physiological indices
      to predict training effects. This study capitalizes on the groundwork for non-pharmacological
      intervention of cognitive decline after stroke.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: fMRI (change is being assessed)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months).
description: Resting-state functional connectivity and neural activation in the frontal, parietal and occipital lobes
measure: Serum BDNF level
time frame: Baseline, posttest (an expected average of 3 months)
description: Up-regulation of neurotrophic and vascular growth factors
measure: Antioxidative marker
time frame: Baseline, posttest (an expected average of 3 months)]
description: Antioxidative markers will be used to reflect the changes on oxidative stress. In particular, we will be analyzing the total antioxidant capacity (TAC).
measure: Glucose indicator
time frame: Baseline, posttest (an expected average of 3 months)
description: HbA1C level will be tested to investigate the relationships between blood glucose level and aerobic exercise
measure: Plasma lipid level
time frame: Baseline, posttest (an expected average of 3 months)
description: The cholesterol ratio (total cholesterol divided by high-density lipid) will be evaluated to reflect the lipid level in the blood
measure: Montreal Cognitive Assessment (MoCA)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The MoCA will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30
measure: Wechsler Memory Scale - Third Edition (WMS-III)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The WMS-III is a standardized and reliable neuropsychological examination tool designed to evaluate visuospatial and memory functions
measure: Wechsler Adult Intelligence Scale - Third Edition (WAIS-III)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The WAIS-III is developed to measure an individual's intelligence level. It includes tests that evaluate cognitive functions in verbal comprehension, working memory, perceptual organization, and processing speed
measure: Useful Field of View (UFOV)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The UFOV assessment is a computer-based visual test containing three subtests: visuomotor processing speed, divided attention, and selective attention.
measure: Stroop Color-Word test
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The Stroop Color-Word assesses the abilities of selective attention, inhibition and executive function. The participants will be tested under congruent and incongruent conditions.
measure: Dual-task test
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The dual-task test evaluates the ability to shift attention between one task and another. Participants will perform the box and block test (BBT) while doing secondary cognitive tasks while sitting. Participants will perform BBT by affected and less affected hand.
measure: Time up and go test (TUG)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The TUG assesses the dynamic balance ability and mobility. The participants will be required to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down.
measure: Six-minute walk test (6MWT)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The 6MWT measures the maximum distance walked over 6 minutes, which assess the endurance and mobility level of the participants. The participants could rest as needed during the course of the test.
measure: International Physical Activity Questionnaires (IPAQ)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The IPAQ is an international measure of health-related physical activity.
measure: Fugl-Meyer Assessment (FMA)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The 33-item upper limb subscale of the FMA will be used to assess motor impairments.
measure: Rivermead Mobility Index (RMI)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The RMI evaluates the participant's bed mobility, postural transfers and walking ability. It contains a 15-item scale which includes 14 questions and one direct observation, with a total of score of 15.
measure: Muscle strength
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.
measure: Mobility level
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: Accelerometers will be used to provide an objective measure of the amount of arm movements in real-life situations. The participants will be asked to wear an Actigraphy activity monitor.
measure: Functional Independence Measure (FIM)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The FIM assesses the dependence level of individuals with stroke to perform 18 activities (13 motor and five cognitive tasks) in daily living. The score ranges from 18 to 126 and higher scores demonstrate greater independent participation in daily activities.
measure: Lawton Instrumental Activities of Daily Living Scale (Lawton LADL)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The Lawton IADL scale assesses independent living skills, such as shopping or managing finances.
measure: Stroke Impact Scale (SIS)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.
measure: Caregiver Burden Scale (CB scale)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: B scale evaluates the burden of the primary caregiver of the participants. Lessening the burden of caregivers after the intervention may significantly improve the quality of life for patients with stroke and their family.
measure: EuroQol-5D questionnaire (EQ-5D)
time frame: Baseline, posttest (an expected average of 3 months), follow-up (up to 9 months)
description: The quality of life will be assessed by the EQ-5D questionnaire which comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
arm group label: Sequential training group
arm group type: Experimental
description: Exercise training for 30 minutes followed by 30 minutes of cognitive-based intervention
arm group label: Dual training group
arm group type: Experimental
description: Exercise training simultaneously combined cognitive-based intervention for 60 minutes
arm group label: Control training group
arm group type: Active Comparator
description: non-aerobic exercise (e.g., stretch, range of motion exercise...) and unstructured cognitive rehabilitation programs (e.g., reading newspapers, playing board games...) for 60 minutes
intervention type: Behavioral
intervention name: Sequential training
description: The participant will cycle on a stationary bike for 30 minutes, which includes a 3-min warm-up phase followed by the aerobic training components (25 minutes), then a 2-min cool-down phase. The target heart rate during the aerobic training phase will be 40 to 70% of maximal heart rate (HRmax). After cycling, the participant will engage in a 30-minute of computer-based cognitive training program using BrainHQ (Posit Science Inc., San Francisco, CA, USA). The following are the areas of training: visuospatial processing, attention, memory, language, and logical thinking.
arm group label: Sequential training group
intervention type: Behavioral
intervention name: Dual training
description: The dual-task training group will cycling concurrently with the computer-based cognitive training. The training principle of cycling and cognitive training is similar to the SEQ group; however, the training intensity will be adjusted according to each participant's ability.
arm group label: Dual training group
intervention type: Behavioral
intervention name: Control training
description: The control participants will receive 60 minutes of health-related rehabilitation programs which involves non-aerobic physical exercise (e.g., muscle stretching, range of motion exercises, relaxation techniques) and unstructured cognitive related rehabilitation programs (e.g., watch health-related videos or read newspapers or magazines and then answer the content-related questions raised by the therapist).
arm group label: Control training group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ching-yi Wu, ScD
role: Principal Investigator
affiliation: Chang Gung University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cognitive Dysfunction