<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/NCT02248649</url>
  </required_header>
  <id_info>
    <org_study_id>N1696-I</org_study_id>
    <nct_id>NCT02248649</nct_id>
  </id_info>
  <brief_title>Telemedicine Intervention to Improve Cognitive Function</brief_title>
  <official_title>A Telemedicine Intervention to Improve Cognitive Function in Patients With PD</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 investigating whether a home-based exercise program will reduce cognitive&#xD;
      decline in patients with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background/Rationale:&#xD;
&#xD;
      Progressive cognitive impairment leading to dementia is an important component of Parkinson's&#xD;
      disease (PD), contributing to significant levels of disability. The number of Veterans who&#xD;
      will develop PD and, in turn, the number of Veterans with PD who develop dementia is likely&#xD;
      to increase substantially. Given the profound negative health and social consequences&#xD;
      associated with the development of dementia, it is critical to identify interventions that&#xD;
      effectively slow the decline of cognitive function to prolong the time to onset of dementia.&#xD;
      Based on the results of prior studies, physical activity is one of the few nonpharmacological&#xD;
      interventions that holds promise in slowing cognitive decline.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      The investigators hypothesize that a home-based physical activity intervention to promote&#xD;
      walking will reduce cognitive decline in Veterans with mild cognitive impairment in PD&#xD;
      (PD-MCI).&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      The proposed study is a randomized, controlled trial of a home-based walking intervention,&#xD;
      evaluating effects on cognitive function. Community-dwelling Veterans with PD-MCI will be&#xD;
      randomized to a walking intervention or a health education control intervention. Subjects&#xD;
      will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with&#xD;
      at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and MCI. The&#xD;
      interventions will last 18 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2014</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 15, 2018</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12</measure>
    <time_frame>Baseline and 12 months</time_frame>
    <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18</measure>
    <time_frame>Baseline and 18 month</time_frame>
    <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Physical Activity</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Structured walking program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Health education attention control</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured physical activity</intervention_name>
    <description>Walking instruction and encouragement</description>
    <arm_group_label>Physical Activity</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</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physician diagnosis of idiopathic, typical Parkinson's disease (PD)&#xD;
&#xD;
          -  At least 2 of 3 cardinal signs of PD&#xD;
&#xD;
          -  Response to dopaminergic medication&#xD;
&#xD;
          -  Mild cognitive impairment&#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>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David W 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>May 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>May 20, 2019</results_first_submitted>
  <results_first_submitted_qc>May 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2019</results_first_posted>
  <last_update_submitted>May 20, 2019</last_update_submitted>
  <last_update_submitted_qc>May 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Exercise therapy</keyword>
  <keyword>Mild cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 2, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT02248649/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Physical Activity</title>
          <description>Structured walking program&#xD;
Structured physical activity: Walking instruction and encouragement</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Health education attention control&#xD;
Health education: Provision of general information about a variety of health topics&#xD;
Provision of general information about a variety of health</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Physical Activity</title>
          <description>Structured walking program&#xD;
Structured physical activity: Walking instruction and encouragement</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Health education attention control&#xD;
Health education: Provision of general information about a variety of health topics&#xD;
Provision of general information about a variety of health</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="80"/>
            <count group_id="B2" value="80"/>
            <count group_id="B3" value="160"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="80"/>
                    <count group_id="B3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.8" spread="8.6"/>
                    <measurement group_id="B2" value="74.6" spread="8.3"/>
                    <measurement group_id="B3" value="74.7" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="80"/>
                    <count group_id="B3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="80"/>
                    <count group_id="B3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="80"/>
                    <count group_id="B3" value="160"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.6" spread="2.8"/>
                    <measurement group_id="B2" value="14.1" spread="2.5"/>
                    <measurement group_id="B3" value="13.8" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6</title>
        <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>number of participants analyzed: participants with ADAS-Cog scores at baseline and at 6 months. 4 participants in Physical Activity group and 6 participants in Control group did not have a score at 6 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity</title>
            <description>Structured walking program&#xD;
Structured physical activity: Walking instruction and encouragement</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Health education attention control&#xD;
Health education: Provision of general information about a variety of health topics&#xD;
Provision of general information about a variety of health</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6</title>
          <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.</description>
          <population>number of participants analyzed: participants with ADAS-Cog scores at baseline and at 6 months. 4 participants in Physical Activity group and 6 participants in Control group did not have a score at 6 months.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.24" spread="0.62"/>
                    <measurement group_id="O2" value="0.95" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2</p_value>
            <method>Mixed Models Analysis</method>
            <method_desc>covariates: baseline age and years of education</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12</title>
        <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.</description>
        <time_frame>Baseline and 12 months</time_frame>
        <population>number of participants analyzed: participants with ADAS-Cog scores at baseline and at 12 months. 17 participants in Physical Activity group and 15 participants in Control group did not have a score at 12 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity</title>
            <description>Structured walking program&#xD;
Structured physical activity: Walking instruction and encouragement</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Health education attention control&#xD;
Health education: Provision of general information about a variety of health topics&#xD;
Provision of general information about a variety of health</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12</title>
          <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.</description>
          <population>number of participants analyzed: participants with ADAS-Cog scores at baseline and at 12 months. 17 participants in Physical Activity group and 15 participants in Control group did not have a score at 12 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.12" spread="0.79"/>
                    <measurement group_id="O2" value="2.60" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.04</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18</title>
        <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.</description>
        <time_frame>Baseline and 18 month</time_frame>
        <population>number of participants analyzed: participants with ADAS-Cog scores at baseline and at 18 months. 21 participants in Physical Activity group and 21 participants in Control group did not have a score at 18 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Physical Activity</title>
            <description>Structured walking program&#xD;
Structured physical activity: Walking instruction and encouragement</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Health education attention control&#xD;
Health education: Provision of general information about a variety of health topics&#xD;
Provision of general information about a variety of health</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18</title>
          <description>The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.</description>
          <population>number of participants analyzed: participants with ADAS-Cog scores at baseline and at 18 months. 21 participants in Physical Activity group and 21 participants in Control group did not have a score at 18 months.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="0.99"/>
                    <measurement group_id="O2" value="3.60" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>18 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Physical Activity</title>
          <description>Structured walking program&#xD;
Structured physical activity: Walking instruction and encouragement</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Health education attention control&#xD;
Health education: Provision of general information about a variety of health topics&#xD;
Provision of general information about a variety of health</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="80"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. David Sparrow</name_or_title>
      <organization>VA Boston Healthcare System</organization>
      <phone>857-364-6407</phone>
      <email>david.sparrow@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02248649
org study id: N1696-I
nct id: NCT02248649
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This project is investigating whether a home-based exercise program will reduce cognitive
      decline in patients with Parkinson's disease.
Background/Rationale:

      Progressive cognitive impairment leading to dementia is an important component of Parkinson's
      disease (PD), contributing to significant levels of disability. The number of Veterans who
      will develop PD and, in turn, the number of Veterans with PD who develop dementia is likely
      to increase substantially. Given the profound negative health and social consequences
      associated with the development of dementia, it is critical to identify interventions that
      effectively slow the decline of cognitive function to prolong the time to onset of dementia.
      Based on the results of prior studies, physical activity is one of the few nonpharmacological
      interventions that holds promise in slowing cognitive decline.

      Objective:

      The investigators hypothesize that a home-based physical activity intervention to promote
      walking will reduce cognitive decline in Veterans with mild cognitive impairment in PD
      (PD-MCI).

      Methods:

      The proposed study is a randomized, controlled trial of a home-based walking intervention,
      evaluating effects on cognitive function. Community-dwelling Veterans with PD-MCI will be
      randomized to a walking intervention or a health education control intervention. Subjects
      will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with
      at least 2 of 3 cardinal signs of PD, response to dopaminergic medication, and MCI. The
      interventions will last 18 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 6
time frame: Baseline and 6 months
description: The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 6-month - Score at Baseline.
measure: Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 12
time frame: Baseline and 12 months
description: The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.
measure: Change From Baseline on Cognitive Section of Alzheimer Disease Assessment Scale (ADAS-Cog) at Month 18
time frame: Baseline and 18 month
description: The ADAS-Cog includes items assessing memory, orientation, language, and praxis. Scores range from 0-70 (higher scores indicate worse cognitive function). Change = Score at 12-month - Score at Baseline.
arm group label: Physical Activity
arm group type: Experimental
description: Structured walking program
arm group label: Control
arm group type: Active Comparator
description: Health education attention control
intervention type: Behavioral
intervention name: Structured physical activity
description: Walking instruction and encouragement
arm group label: Physical Activity
intervention type: Behavioral
intervention name: Health education
description: Provision of general information about a variety of health topics
arm group label: Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: David W 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: Parkinson Disease
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 