<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/NCT03824639</url>
  </required_header>
  <id_info>
    <org_study_id>E2545-P</org_study_id>
    <nct_id>NCT03824639</nct_id>
  </id_info>
  <brief_title>Exercise Training to Improve Cognitive Function</brief_title>
  <official_title>Exercise Training to Improve Cognitive Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is assessing the feasibility of a novel home-based exercise intervention to&#xD;
      improve episodic memory in individuals with mild cognitive impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Rationale:&#xD;
&#xD;
      Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in&#xD;
      coming decades. AD is known to have a long preclinical phase in which pathophysiologic&#xD;
      processes develop many years, even decades, before the onset of clinical symptoms. During&#xD;
      this preclinical phase there is evidence of unremitting decline in cognitive function,&#xD;
      particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological&#xD;
      interventions to slow this decline in cognitive function has been limited, leading to&#xD;
      increasing interest in the utility of nonpharmacological interventions including exercise.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The investigators propose to assess the feasibility of a novel home-based exercise&#xD;
      intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The investigators will estimate the difference between the intervention (n=30) and the&#xD;
      control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure&#xD;
      Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis&#xD;
      for sample size calculation for a proposed larger study. Participants will be male and female&#xD;
      Veterans 50 years of age or older with amnestic MCI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 23, 2019</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>Phase 3</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wechsler Logical Memory Task</measure>
    <time_frame>6 months</time_frame>
    <description>A recall test involving 2 short stories</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rey-Osterrieth Complex Figure Test</measure>
    <time_frame>6 months</time_frame>
    <description>A recall test involving a complex figure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Mild Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured exercise</intervention_name>
    <description>Exercise instruction and encouragement</description>
    <arm_group_label>Exercise group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education</intervention_name>
    <description>Provision of general information about a variety of health topics</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Amnestic MCI&#xD;
&#xD;
          -  Ability to use a telephone without assistance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Angina Pectoris&#xD;
&#xD;
          -  History of myocardial infarction within 6 months&#xD;
&#xD;
          -  History of ventricular dysrhythmia requiring current therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David William Sparrow, DSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 18, 2022</last_update_submitted>
  <last_update_submitted_qc>August 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mild cognitive impairment</keyword>
  <keyword>exercise therapy</keyword>
  <keyword>patient adherence</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>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03824639/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>June 6, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03824639
org study id: E2545-P
nct id: NCT03824639
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This project is assessing the feasibility of a novel home-based exercise intervention to
      improve episodic memory in individuals with mild cognitive impairment.
Background/Rationale:

      Alzheimer's disease (AD) afflicts nearly 6 million Americans, a number projected to grow in
      coming decades. AD is known to have a long preclinical phase in which pathophysiologic
      processes develop many years, even decades, before the onset of clinical symptoms. During
      this preclinical phase there is evidence of unremitting decline in cognitive function,
      particularly in episodic memory. Thus far, evidence of the efficacy of pharmacological
      interventions to slow this decline in cognitive function has been limited, leading to
      increasing interest in the utility of nonpharmacological interventions including exercise.

      Objective:

      The investigators propose to assess the feasibility of a novel home-based exercise
      intervention to improve episodic memory in Veterans with mild cognitive impairment (MCI).

      Methods:

      The investigators will estimate the difference between the intervention (n=30) and the
      control group (n=30) on 6-month change in episodic memory (Rey-Osterrieth Complex Figure
      Test, Wechsler Logical Memory Test) as well as the effect size, which will be used as a basis
      for sample size calculation for a proposed larger study. Participants will be male and female
      Veterans 50 years of age or older with amnestic MCI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Wechsler Logical Memory Task
time frame: 6 months
description: A recall test involving 2 short stories
measure: Rey-Osterrieth Complex Figure Test
time frame: 6 months
description: A recall test involving a complex figure
arm group label: Exercise group
arm group type: Experimental
description: Structured exercise
arm group label: Control group
arm group type: Active Comparator
description: Health education
intervention type: Behavioral
intervention name: Structured exercise
description: Exercise instruction and encouragement
arm group label: Exercise group
intervention type: Behavioral
intervention name: Health Education
description: Provision of general information about a variety of health topics
arm group label: Control group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: David William Sparrow, DSc
role: Principal Investigator
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
sharing ipd: No
provided document: 
submitted: June 6, 2023