<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/NCT03789409</url>
  </required_header>
  <id_info>
    <org_study_id>chhwang11</org_study_id>
    <nct_id>NCT03789409</nct_id>
  </id_info>
  <brief_title>Intermittent Fasting Following Acute Ischemic Stroke</brief_title>
  <official_title>Intermittent Fasting Following Acute Ischemic Stroke: Prospective, Randomized, Parallel Group, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ulsan University 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>
      Despite numerous kinds of evidence on functional health and CNS protection of intermittent&#xD;
      fasting after injuries were found in many brain-, and spinal cord-damaged animal models,&#xD;
      there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral&#xD;
      infarction. The aim of this study is to evaluate the neurological, functional and clinical&#xD;
      efficacy of intermittent fasting in patients after acute ischemic stroke.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to verify the validity and clinical efficacy of intermittent fasting for&#xD;
      neurological and functional effects of ischemic cerebral infarction, the first ischemic&#xD;
      stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to&#xD;
      intermittent fasting group or control group. In both groups, physical therapy, occupational&#xD;
      therapy and speech therapy will be provided during 3 hours in total a day. The intermittent&#xD;
      fasting group should maintain intermittent fasting for no less than 12 hours or more every&#xD;
      day during the rehabilitation period (at least 1 week), and the control group is able to eat&#xD;
      all of the hospital meals and all the participants want without any time limit. The efficacy&#xD;
      of intermittent fasting is to be verified by performing the electro-physiological tests and&#xD;
      functional evaluations before participation, 1st week, 2nd weeks after participation, before&#xD;
      discharge, 3 months, and 6 months after the stroke onset.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 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>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Surface electromyography</measure>
    <time_frame>1 day before the initiation of intervention, and 6 months after the stroke onset</time_frame>
    <description>root mean square and root peak square of compound motor action potential</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Korean-modified Barthel index</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Korean version-Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of Mini mental status exam</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Mini mental status exam(minimum of 0 and maximum scores of 30); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Beck depression inventory</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Beck depression inventory(minimum of 0 and maximum scores of 63); higher values and a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Wecsler aphasia battery</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Wecsler aphasia battery(minimum of 0 and maximum scores of 100); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Berg balance scale</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Berg balance scale(minimum of 0 and maximum scores of 56); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Functional Ambulation Category</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Functional Ambulation Category(minimum of 0 and maximum scores of 5); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Motricity Index</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Motricity Index(minimum of 0 and maximum scores of 99); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of 10m walking test</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>10m walking test</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Grasping force (kg)</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Grasping force (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of 9-hole pegboard</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>9-hole pegboard</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Jebsen Taylor test</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Jebsen-Taylor Hand Function Test</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Nottingham sensory scale</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Nottingham sensory scale(minimum of 0 and maximum scores of 20); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Arm motor Fugl-Mayer scale</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Arm motor Fugl-Mayer scale; wrist &amp; hand/proximal arm(minimum of 0 and maximum scores of 24 and of 34, respectively ); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Stroke impact scale</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Hand motor, Stroke Impact Scale (minimum of 12 and maximum scores of 60); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Ashworth scale</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Ashworth scale; elbow, wrist, knee &amp; ankle(minimum of 0 and maximum scores of 4); higher values and a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Knee joint kinesthesia</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>The smallest iso-kinetic angle from which the participants could detect any passive flexion or extension movement of their own knee, using Biodex; (minimum of 0 and maximum scores of 360 degree); higher values and a worse outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Behavioral inatention test</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Behavioral inatention test(minimum of 0 and maximum scores of 146); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Apraxia screen of Tulia</measure>
    <time_frame>1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset</time_frame>
    <description>Apraxia screen of (minimum of 0 and maximum scores of 12); higher values and a better outcome.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of motor evoked potential</measure>
    <time_frame>1 day before the initiation of intervention, and 6 months after the stroke onset</time_frame>
    <description>Amplitude (uV) of motor evoked potential was recorded on abductor pollicis brevis and extentor digitorum brevis following trans-cranial magnetic stimulation for cortico-spinal excitability.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Weight</measure>
    <time_frame>1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention</time_frame>
    <description>Weight (Kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Temperature</measure>
    <time_frame>1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention</time_frame>
    <description>temperature (Celsius)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Serum glucose level</measure>
    <time_frame>1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention</time_frame>
    <description>Serum glucose level (mg/ml)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of Hypoglycemia-related severity</measure>
    <time_frame>every day following the start of intervention until 2 weeks of intervention</time_frame>
    <description>Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">68</enrollment>
  <condition>Ischemic Stroke</condition>
  <condition>Intermittent Fasting</condition>
  <arm_group>
    <arm_group_label>Intermittent Fasting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Over rehabilitation treatment during and admission (at least 1 week), intermittent fasting (IF) for more than 12 hours (water can be allowed). For subgroup assignment, participants can choose IF1 (eat early in the evening and late in the morning) or Post-IF2 (eat the remaining two meals without breakfast), depending on own their faver.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ad libitium</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be allowed to have hospital meals and all the desired intake without time limit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Intermittent Fasting</intervention_name>
    <description>The aforementioned intermittent fasting in arm/group descriptions.</description>
    <arm_group_label>Intermittent Fasting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who was diagnosed first ischemic stroke within preceeding 1 year through&#xD;
             brain MRI/CT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Musculo-skeletal disease with limbs malformation or joint contracture&#xD;
&#xD;
          -  Weigh more than 135 kg or taller than 195 cm&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  unstable patient in neurology&#xD;
&#xD;
          -  Refusal of participation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chang Ho Hwang</last_name>
    <phone>+82-52-250-7210</phone>
    <email>chhwang1220ciba@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>682-714</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
      <phone>+82-52-250-7210</phone>
      <email>chhwang1220ciba@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Chang Ho Hwang, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>December 15, 2019</last_update_submitted>
  <last_update_submitted_qc>December 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ulsan University Hospital</investigator_affiliation>
    <investigator_full_name>Chang Ho Hwang</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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>Cerebral Infarction</mesh_term>
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03789409
org study id: chhwang11
nct id: NCT03789409
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite numerous kinds of evidence on functional health and CNS protection of intermittent
      fasting after injuries were found in many brain-, and spinal cord-damaged animal models,
      there has yet to be any clinical study of intermittent fasting after acute ischemic cerebral
      infarction. The aim of this study is to evaluate the neurological, functional and clinical
      efficacy of intermittent fasting in patients after acute ischemic stroke.
In order to verify the validity and clinical efficacy of intermittent fasting for
      neurological and functional effects of ischemic cerebral infarction, the first ischemic
      stroke (diagnosed within 1 year through brain MRI / CT) patients will be randomly assigned to
      intermittent fasting group or control group. In both groups, physical therapy, occupational
      therapy and speech therapy will be provided during 3 hours in total a day. The intermittent
      fasting group should maintain intermittent fasting for no less than 12 hours or more every
      day during the rehabilitation period (at least 1 week), and the control group is able to eat
      all of the hospital meals and all the participants want without any time limit. The efficacy
      of intermittent fasting is to be verified by performing the electro-physiological tests and
      functional evaluations before participation, 1st week, 2nd weeks after participation, before
      discharge, 3 months, and 6 months after the stroke onset.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change of Surface electromyography
time frame: 1 day before the initiation of intervention, and 6 months after the stroke onset
description: root mean square and root peak square of compound motor action potential
measure: Change of Korean-modified Barthel index
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Korean version-Modified Barthel Index (minimum of 0 and maximum scores of 100); higher values and a better outcome.
measure: Change of Mini mental status exam
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Mini mental status exam(minimum of 0 and maximum scores of 30); higher values and a better outcome.
measure: Change of Beck depression inventory
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Beck depression inventory(minimum of 0 and maximum scores of 63); higher values and a worse outcome.
measure: Change of Wecsler aphasia battery
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Wecsler aphasia battery(minimum of 0 and maximum scores of 100); higher values and a better outcome.
measure: Change of Berg balance scale
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Berg balance scale(minimum of 0 and maximum scores of 56); higher values and a better outcome.
measure: Change of Functional Ambulation Category
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Functional Ambulation Category(minimum of 0 and maximum scores of 5); higher values and a better outcome.
measure: Change of Motricity Index
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Motricity Index(minimum of 0 and maximum scores of 99); higher values and a better outcome.
measure: Change of 10m walking test
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: 10m walking test
measure: Change of Grasping force (kg)
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Grasping force (kg)
measure: Change of 9-hole pegboard
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: 9-hole pegboard
measure: Change of Jebsen Taylor test
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Jebsen-Taylor Hand Function Test
measure: Change of Nottingham sensory scale
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Nottingham sensory scale(minimum of 0 and maximum scores of 20); higher values and a better outcome.
measure: Change of Arm motor Fugl-Mayer scale
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Arm motor Fugl-Mayer scale; wrist & hand/proximal arm(minimum of 0 and maximum scores of 24 and of 34, respectively ); higher values and a better outcome.
measure: Change of Stroke impact scale
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Hand motor, Stroke Impact Scale (minimum of 12 and maximum scores of 60); higher values and a better outcome.
measure: Change of Ashworth scale
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Ashworth scale; elbow, wrist, knee & ankle(minimum of 0 and maximum scores of 4); higher values and a worse outcome.
measure: Change of Knee joint kinesthesia
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: The smallest iso-kinetic angle from which the participants could detect any passive flexion or extension movement of their own knee, using Biodex; (minimum of 0 and maximum scores of 360 degree); higher values and a worse outcome.
measure: Change of Behavioral inatention test
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Behavioral inatention test(minimum of 0 and maximum scores of 146); higher values and a better outcome.
measure: Change of Apraxia screen of Tulia
time frame: 1 day before the initiation of intervention and 3rd week after start of intervention, 3 months and 6 months after the stroke onset
description: Apraxia screen of (minimum of 0 and maximum scores of 12); higher values and a better outcome.
measure: Change of motor evoked potential
time frame: 1 day before the initiation of intervention, and 6 months after the stroke onset
description: Amplitude (uV) of motor evoked potential was recorded on abductor pollicis brevis and extentor digitorum brevis following trans-cranial magnetic stimulation for cortico-spinal excitability.
measure: Change of Weight
time frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
description: Weight (Kg)
measure: Change of Temperature
time frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
description: temperature (Celsius)
measure: Change of Serum glucose level
time frame: 1 day before the start of intervention and 1 weeks and 2 weeks after the start of intervention
description: Serum glucose level (mg/ml)
measure: Change of Hypoglycemia-related severity
time frame: every day following the start of intervention until 2 weeks of intervention
description: Assessment of hypoglycemic symptoms using Likert scale (minimum of 0 and maximum scores of 10); higher values and a worse outcome.
arm group label: Intermittent Fasting
arm group type: Experimental
description: Over rehabilitation treatment during and admission (at least 1 week), intermittent fasting (IF) for more than 12 hours (water can be allowed). For subgroup assignment, participants can choose IF1 (eat early in the evening and late in the morning) or Post-IF2 (eat the remaining two meals without breakfast), depending on own their faver.
arm group label: Ad libitium
arm group type: No Intervention
description: Participants will be allowed to have hospital meals and all the desired intake without time limit.
intervention type: Dietary Supplement
intervention name: Intermittent Fasting
description: The aforementioned intermittent fasting in arm/group descriptions.
arm group label: Intermittent Fasting
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chang Ho Hwang, M.D., Ph.D.
role: Study Director
affiliation: Ulsan University Hospital
last name: Chang Ho Hwang
phone: +82-52-250-7210
email: chhwang1220ciba@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ulsan University Hospital
investigator full name: Chang Ho Hwang
investigator title: Associate Professor
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Cerebral Infarction
mesh term: Ischemia
sharing ipd: No