xml: <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/NCT05963152</url>
    </required_header>
    <id_info>
      <org_study_id>RA HM-2023-010</org_study_id>
      <nct_id>NCT05963152</nct_id>
    </id_info>
    <brief_title>Resistance Exercise and Cognition in People With Type 1 Diabetes</brief_title>
    <official_title>The Effects of Resistance Exercise on Cognition in People With Type 1 Diabetes: a Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dasman Diabetes Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dasman Diabetes Institute</source>
    <oversight_info>
      <has_dmc>No</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 aim of the current study is to determine the effects of resistance exercise on&#xD;
        performance of the Paced Auditory Serial Addition Test and the Colour Trails Test.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</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>
      <intervention_model_description>1:1:1 parallel group design</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Chronic change in Paced Auditory Serial Addition Test (PASAT) score</measure>
      <time_frame>Change from baseline to 12 weeks</time_frame>
      <description>Measured using the standardised Paced Auditory Serial Addition Test (PASAT) score ranging from 0-60 with a higher score meaning a better outcome</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Chronic change in Colour Trails Test score</measure>
      <time_frame>Change from baseline to 12 weeks</time_frame>
      <description>Measured using the standardised Colour Trails Test, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score</measure>
      <time_frame>Change from before (0 hour) to 1 hour post exercise during week 1</time_frame>
      <description>Measured using the standardised Paced Auditory Serial Addition Test (PASAT) during the first exercise session, score ranging from 0-60 with a higher score meaning a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12 week acute change in Paced Auditory Serial Addition Test (PASAT) score</measure>
      <time_frame>Change from before (0 hour) to 1 hour post exercise during week 12</time_frame>
      <description>Measured using the standardised Paced Auditory Serial Addition Test (PASAT) during the last exercise session, score ranging from 0-60 with a higher score meaning a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Baseline acute change in Colour Trails Test score</measure>
      <time_frame>Change from before (0 hour) to 1 hour post exercise during week 1</time_frame>
      <description>Measured using the standardised Colour Trails Test during the first exercise session, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>12 week acute change in Colour Trails Test score</measure>
      <time_frame>Change from before (0 hour) to 1 hour post exercise during week 12</time_frame>
      <description>Measured using the standardised Colour Trails Test during the last exercise session, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>type1diabetes</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Habitual Physical Activity</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Morning exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise training between 6-10am</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Afternoon exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Exercise training between 4-8pm</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Habitual Physical Activity</intervention_name>
      <description>Participants will be asked to maintain their normal activity levels</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Morning Exercise</intervention_name>
      <description>Between 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)</description>
      <arm_group_label>Morning exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Afternoon Exercise</intervention_name>
      <description>Between 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)</description>
      <arm_group_label>Afternoon exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Physician confirmed type 1 diabetes for at least 1 year&#xD;
  &#xD;
            -  Stable insulin therapy for 3 months prior to the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI of 45 or higher&#xD;
  &#xD;
            -  BP of 160/100mmHg or higher&#xD;
  &#xD;
            -  autonomic neuropathy&#xD;
  &#xD;
            -  severe proliferative retinopathy&#xD;
  &#xD;
            -  joint or limb injuries preventing weight-bearing activity&#xD;
  &#xD;
            -  autonomic neuropathy&#xD;
  &#xD;
            -  severe proliferative retinopathy&#xD;
  &#xD;
            -  any other medical condition that prevents participants from exercising safely.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ebaa AlOzairi</last_name>
      <phone>+965 22242999</phone>
      <phone_ext>3111</phone_ext>
      <email>ebaa.alozairi@dasmaninstitute.rog</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dasman Diabetes Institute</name>
        <address>
          <city>Kuwait City</city>
          <zip>15462</zip>
          <country>Kuwait</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ebaa AlOZairi</last_name>
      </contact>
      <investigator>
        <last_name>Ebaa AlOzairi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Kuwait</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dasman Diabetes Institute</investigator_affiliation>
      <investigator_full_name>Dr. Ebaa Al Ozairi</investigator_full_name>
      <investigator_title>Chief Medical Officer</investigator_title>
    </responsible_party>
    <keyword>exercise</keyword>
    <keyword>cognition</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963152
  org study id: RA HM-2023-010
  nct id: NCT05963152
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the current study is to determine the effects of resistance exercise on
        performance of the Paced Auditory Serial Addition Test and the Colour Trails Test.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: 1:1:1 parallel group design
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Chronic change in Paced Auditory Serial Addition Test (PASAT) score
  time frame: Change from baseline to 12 weeks
  description: Measured using the standardised Paced Auditory Serial Addition Test (PASAT) score ranging from 0-60 with a higher score meaning a better outcome
  measure: Chronic change in Colour Trails Test score
  time frame: Change from baseline to 12 weeks
  description: Measured using the standardised Colour Trails Test, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome
  measure: Baseline acute change in Paced Auditory Serial Addition Test (PASAT) score
  time frame: Change from before (0 hour) to 1 hour post exercise during week 1
  description: Measured using the standardised Paced Auditory Serial Addition Test (PASAT) during the first exercise session, score ranging from 0-60 with a higher score meaning a better outcome
  measure: 12 week acute change in Paced Auditory Serial Addition Test (PASAT) score
  time frame: Change from before (0 hour) to 1 hour post exercise during week 12
  description: Measured using the standardised Paced Auditory Serial Addition Test (PASAT) during the last exercise session, score ranging from 0-60 with a higher score meaning a better outcome
  measure: Baseline acute change in Colour Trails Test score
  time frame: Change from before (0 hour) to 1 hour post exercise during week 1
  description: Measured using the standardised Colour Trails Test during the first exercise session, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome
  measure: 12 week acute change in Colour Trails Test score
  time frame: Change from before (0 hour) to 1 hour post exercise during week 12
  description: Measured using the standardised Colour Trails Test during the last exercise session, with score based on completion time (0-240s), number of errors, error type, and number of prompts with a shorter completion time and lower number of errors and prompts indicating a better outcome
  arm group label: Control
  arm group type: Placebo Comparator
  description: Habitual Physical Activity
  arm group label: Morning exercise
  arm group type: Experimental
  description: Exercise training between 6-10am
  arm group label: Afternoon exercise
  arm group type: Experimental
  description: Exercise training between 4-8pm
  intervention type: Behavioral
  intervention name: Habitual Physical Activity
  description: Participants will be asked to maintain their normal activity levels
  arm group label: Control
  intervention type: Behavioral
  intervention name: Morning Exercise
  description: Between 6-10am participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)
  arm group label: Morning exercise
  intervention type: Behavioral
  intervention name: Afternoon Exercise
  description: Between 4-8pm participants will attend the gym and perform 10 min of warm up exercise, 3 sets of 7 resistance exercises ( leg press, calf press, leg curl, chest press, lateral raise, seated row and plank)
  arm group label: Afternoon exercise
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Ebaa AlOzairi
  phone: +965 22242999
  phone ext: 3111
  email: ebaa.alozairi@dasmaninstitute.rog
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Kuwait
  responsible party type: Principal Investigator
  investigator affiliation: Dasman Diabetes Institute
  investigator full name: Dr. Ebaa Al Ozairi
  investigator title: Chief Medical Officer
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No