<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/NCT03254381</url>
  </required_header>
  <id_info>
    <org_study_id>109379</org_study_id>
    <nct_id>NCT03254381</nct_id>
  </id_info>
  <brief_title>The Effect of Exercise on Cognition in Older Adults At-risk for Diabetes: A Feasibility Pilot Study</brief_title>
  <official_title>The Effect of Resistance Training on Cognitive Function and Brain Health in Older Adults At-risk for Diabetes: A Feasibility Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</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>
      Older adults with type 2 diabetes experience cognitive decline and are at higher risk for&#xD;
      developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based&#xD;
      on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at&#xD;
      this point may prevent or delay the onset of such decline. One promising lifestyle&#xD;
      intervention that has been shown to improve cognitive function in other populations is&#xD;
      exercise. However, before investigators can examine whether exercise will improve cognitive&#xD;
      function and brain health (structure and function) in this at-risk population, a feasibility&#xD;
      pilot study is needed to determine whether a larger-scale trial would be viable.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will conduct a six-month randomized control trial (RCT) exercise intervention.&#xD;
      Thirty older adults (aged 60-80) at-risk for diabetes will be randomly assigned into one of&#xD;
      two groups: 1) Resistance training, or 2) Balance and Tone training (control). All&#xD;
      participants will engage in three one-hour exercise classes per week. Once a month, a neutral&#xD;
      assessor will visit the classes to evaluate the quality of the classes for participants.&#xD;
      Assessments will be made at baseline, midpoint (three months) and trial completion (six&#xD;
      months), and will include cognitive testing, health questionnaires, physical testing, and&#xD;
      magnetic resonance imaging (MRI; to assess structural and functional brain changes).&#xD;
      Throughout the study, investigators will examine data for trends in successful recruitment&#xD;
      strategies and rates of recruitment and adherence to inform future clinical trials in this&#xD;
      population. Research assistants (n = 30) in the study will complete an anonymous feedback&#xD;
      survey upon completion of their volunteer term, to assist in improving the study for future&#xD;
      participants and volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 2, 2017</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants recruited after 12 months</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of exercise classes attended at trial completion (6 months)</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hippocampal volume as measured via high resolution T1 images collected during MRI scanning in both 3T and 7T machines.</measure>
    <time_frame>Baseline and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hippocampal functional activation as measured during performance on associative memory task during fMRI scanning</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>For this task, participants will be asked to encode and then recall items (face or places) and items in conjunction (faces matched with places)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in memory as measured by performance on associative memory task</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in executive functions as measured by Stroop Test</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in aerobic fitness as measured by six minute walk test</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mobility and balance as measured by Short Physical Performance Battery</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle strength as measured by one-repetition maximum test</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood glucose levels as measured by finger prick glucose test</measure>
    <time_frame>Baseline, 3 months, and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Resistance Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use programmable weight machines along with free weights to target primary muscle groups. In addition, they will complete mini-squats, mini-lunges, and lunge walks. Participants will complete two sets of 6-8 reps. Training stimulus will be increased using the 7RM method - when 2 sets of 6-8 reps are completed with proper form and without discomfort. Investigators will record the number of sets completed and the load lifted for each exercise for each participant at every class.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balance and Tone Training (Control)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exercises will include stretching exercises, range of motion exercises, basic core-strength exercises, balance exercises, and relaxation techniques. Only bodyweight will be applied (i.e., no additional loading). This group controls for confounding variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resistance Training</intervention_name>
    <description>Six months of thrice-weekly resistance training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). Classes will be group classes, with up to five participants in each.</description>
    <arm_group_label>Resistance Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Balance and Tone Training</intervention_name>
    <description>Six months of thrice-weekly stretching and relaxation exercises. Each session will be 60 minutes. Classes will be group classes, with up to five participants in each.</description>
    <arm_group_label>Balance and Tone Training (Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) be community-dwelling 2) be aged 60-80 years 3) be &quot;at-risk&quot; for diabetes, where they&#xD;
        have one of the following: i) blood glucose level of 6.1-7 mmol/L, ii) BMI &gt; 25, or iii)&#xD;
        score &gt; 21 on the CANRISK diabetes questionnaire 4) score &gt; 24/30 on MMSE 5) score &gt; 6/8 on&#xD;
        Lawton and Brody's Independent Activities of Daily Living (IADL) scale 6) have visual&#xD;
        acuity of at least 20/40, with or without corrective lenses 7) speak and understand English&#xD;
        fluently 8) complete the Physical Activity Readiness Questionnaire (PAR-Q) 9) obtain&#xD;
        physician's clearance to start a supervised exercise program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) have a current medical condition for which exercise is contraindicated 2) have&#xD;
        participated regularly in resistance or aerobic training in the last 6 months 3) have been&#xD;
        diagnosed with neurodegenerative disease (including dementia, Alzheimer's disease, or&#xD;
        Parkinson's disease) 4) have experienced a vascular incident (e.g., stroke, myocardial&#xD;
        infarction) 5) have been diagnosed with a psychiatric condition 6) have untreated&#xD;
        depression 7) are currently on hormone replacement therapy 8) have clinically significant&#xD;
        peripheral neuropathy or severe musculoskeletal or joint disease 9) are currently taking&#xD;
        psychotropic medications 10) are unable to participate in MRI (have metal or electronic&#xD;
        implants, or are claustrophobic)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lindsay S Nagamatsu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Western University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lindsay S Nagamatsu, PhD</last_name>
    <phone>519-661-2111</phone>
    <phone_ext>88284</phone_ext>
    <email>lnagamat@uwo.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Community</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsay S Nagamatsu, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Lindsay Nagamatsu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>cognitive assessment</keyword>
  <keyword>cognitive function</keyword>
  <keyword>community dwelling older people</keyword>
  <keyword>pre-diabetes</keyword>
  <keyword>randomized control trial</keyword>
  <keyword>exercise</keyword>
  <keyword>pilot study</keyword>
  <keyword>feasibility study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</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/NCT03254381
org study id: 109379
nct id: NCT03254381
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Older adults with type 2 diabetes experience cognitive decline and are at higher risk for
      developing dementia. Consequently, older adults at-risk for developing type 2 diabetes (based
      on body mass, glucose levels) are at higher risk for cognitive decline, and intervening at
      this point may prevent or delay the onset of such decline. One promising lifestyle
      intervention that has been shown to improve cognitive function in other populations is
      exercise. However, before investigators can examine whether exercise will improve cognitive
      function and brain health (structure and function) in this at-risk population, a feasibility
      pilot study is needed to determine whether a larger-scale trial would be viable.
Investigators will conduct a six-month randomized control trial (RCT) exercise intervention.
      Thirty older adults (aged 60-80) at-risk for diabetes will be randomly assigned into one of
      two groups: 1) Resistance training, or 2) Balance and Tone training (control). All
      participants will engage in three one-hour exercise classes per week. Once a month, a neutral
      assessor will visit the classes to evaluate the quality of the classes for participants.
      Assessments will be made at baseline, midpoint (three months) and trial completion (six
      months), and will include cognitive testing, health questionnaires, physical testing, and
      magnetic resonance imaging (MRI; to assess structural and functional brain changes).
      Throughout the study, investigators will examine data for trends in successful recruitment
      strategies and rates of recruitment and adherence to inform future clinical trials in this
      population. Research assistants (n = 30) in the study will complete an anonymous feedback
      survey upon completion of their volunteer term, to assist in improving the study for future
      participants and volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants recruited after 12 months
time frame: 12 months
measure: Number of exercise classes attended at trial completion (6 months)
time frame: 6 months
measure: Change in cognitive function as measured by Alzheimer's Disease Assessment Scale - Cog - Plus (ADAS-Cog-Plus)
time frame: Baseline, 3 months, and 6 months
measure: Change in hippocampal volume as measured via high resolution T1 images collected during MRI scanning in both 3T and 7T machines.
time frame: Baseline and 6 months
measure: Change in hippocampal functional activation as measured during performance on associative memory task during fMRI scanning
time frame: Baseline and 6 months
description: For this task, participants will be asked to encode and then recall items (face or places) and items in conjunction (faces matched with places)
measure: Change in memory as measured by performance on associative memory task
time frame: Baseline, 3 months, and 6 months
measure: Change in executive functions as measured by Stroop Test
time frame: Baseline, 3 months, and 6 months
measure: Change in aerobic fitness as measured by six minute walk test
time frame: Baseline, 3 months, and 6 months
measure: Change in mobility and balance as measured by Short Physical Performance Battery
time frame: Baseline, 3 months, and 6 months
measure: Change in muscle strength as measured by one-repetition maximum test
time frame: Baseline, 3 months, and 6 months
measure: Change in blood glucose levels as measured by finger prick glucose test
time frame: Baseline, 3 months, and 6 months
arm group label: Resistance Training
arm group type: Experimental
description: Participants will use programmable weight machines along with free weights to target primary muscle groups. In addition, they will complete mini-squats, mini-lunges, and lunge walks. Participants will complete two sets of 6-8 reps. Training stimulus will be increased using the 7RM method - when 2 sets of 6-8 reps are completed with proper form and without discomfort. Investigators will record the number of sets completed and the load lifted for each exercise for each participant at every class.
arm group label: Balance and Tone Training (Control)
arm group type: Experimental
description: Exercises will include stretching exercises, range of motion exercises, basic core-strength exercises, balance exercises, and relaxation techniques. Only bodyweight will be applied (i.e., no additional loading). This group controls for confounding variables such as physical training received by traveling to the training centres, social interaction, and changes in lifestyle secondary to study participation.
intervention type: Behavioral
intervention name: Resistance Training
description: Six months of thrice-weekly resistance training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). Classes will be group classes, with up to five participants in each.
arm group label: Resistance Training
intervention type: Behavioral
intervention name: Balance and Tone Training
description: Six months of thrice-weekly stretching and relaxation exercises. Each session will be 60 minutes. Classes will be group classes, with up to five participants in each.
arm group label: Balance and Tone Training (Control)
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lindsay S Nagamatsu
role: Principal Investigator
affiliation: Western University
last name: Lindsay S Nagamatsu, PhD
phone: 519-661-2111
phone ext: 88284
email: lnagamat@uwo.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Western University, Canada
investigator full name: Lindsay Nagamatsu
investigator title: Assistant Professor
mesh term: Cognitive Dysfunction
sharing ipd: No