<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/NCT02236416</url>
  </required_header>
  <id_info>
    <org_study_id>21933_III/11</org_study_id>
    <nct_id>NCT02236416</nct_id>
  </id_info>
  <brief_title>Physical Exercise for Prevention of Dementia</brief_title>
  <acronym>EPD</acronym>
  <official_title>Physical Exercise and Prevention of Cognitive Decline in Subjects at Risk of Dementia: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Molise</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Molise</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The principal aim of this study is to verify whether a program of supervised, multimodal&#xD;
      physical exercise improves cognitive function and/or reduces the rate of cognitive decline in&#xD;
      older adults&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Community-dwelling volunteers, recruited from social centers, were invited to an in-person&#xD;
      assessment that included a medical history questionnaire and examination, anthropometric&#xD;
      measurements, blood tests for cardiovascular risk, and several outcome measures. Participants&#xD;
      meeting the inclusion criteria were divided in 3 groups (participants without subjective or&#xD;
      objective cognitive impairment, with subjective memory complaints and with mild cognitive&#xD;
      impairments) and randomly assigned (1:1) to an experimental group or a control group, using a&#xD;
      list of random numbers generated by a statistical software. The list was kept in a sealed&#xD;
      envelope and a researcher, not directly involved in the recruitment and in the evaluation of&#xD;
      the participants, assigned the allocation numbers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">July 2020</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of Mini Mental State Examination (MMSE) score from baseline to 48 months</measure>
    <time_frame>Baseline and every 6-12 months, over an intervention period of 48 months</time_frame>
    <description>Scale for grading cognitive function</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of neuropsychological test battery from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>It includes: Frontal Assessment Battery, Rey's Auditory Verbal Learning Test, Prose Memory, Stroop Color Word Interference Test, Attentive Matrices, Raven's Progressive Matrices, Trial Making Test, designs copying with and without programming models.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Geriatric Depression Scale (GDS) from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>A self-report assessment for identifing depression in the elderly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Short-form Health Survey (SF-36) from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>Assessment of health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>Assessment of subjective memory complaint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>Assessment of physical activity level in elderly</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>Functional fitness assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of Composite cognitive score (CCS) from baseline to 48 months</measure>
    <time_frame>Baseline and every 6 -12 months, over an intervention period of 48 months</time_frame>
    <description>It is calculated by averaging the standardized scores (Z-score) of all neuropsychological tests, for assessing the overall changes in cognitive performance.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1000</enrollment>
  <condition>Memory Disorders</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Aging</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Posture Education/Unchanged condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention group</intervention_name>
    <description>Supervised, multimodal physical activity including aerobic, resistance and stretching exercises</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age &gt; 50 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical conditions that compromise survival or limit physical activity&#xD;
&#xD;
          -  Geriatric Depression Scale-15 score of 6 or higher&#xD;
&#xD;
          -  Alcohol intake &gt; 4 units/day&#xD;
&#xD;
          -  Mini- Mental State Examination &lt; 24&#xD;
&#xD;
          -  Clinical Dementia Rating score of 1 or more&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alfonso Di Costanzo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Molise</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Research and Training in Medicine of Aging (CeRMA)</name>
      <address>
        <city>Campobasso</city>
        <state>Molise</state>
        <zip>86100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Molise</investigator_affiliation>
    <investigator_full_name>Alfonso Di Costanzo, MD</investigator_full_name>
    <investigator_title>MD, Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>Dementia</keyword>
  <keyword>Prevention</keyword>
  <keyword>Physical Activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Memory Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- 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/NCT02236416
org study id: 21933_III/11
nct id: NCT02236416
lead sponsor: 
has dmc: No
The principal aim of this study is to verify whether a program of supervised, multimodal
      physical exercise improves cognitive function and/or reduces the rate of cognitive decline in
      older adults
Community-dwelling volunteers, recruited from social centers, were invited to an in-person
      assessment that included a medical history questionnaire and examination, anthropometric
      measurements, blood tests for cardiovascular risk, and several outcome measures. Participants
      meeting the inclusion criteria were divided in 3 groups (participants without subjective or
      objective cognitive impairment, with subjective memory complaints and with mild cognitive
      impairments) and randomly assigned (1:1) to an experimental group or a control group, using a
      list of random numbers generated by a statistical software. The list was kept in a sealed
      envelope and a researcher, not directly involved in the recruitment and in the evaluation of
      the participants, assigned the allocation numbers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change of Mini Mental State Examination (MMSE) score from baseline to 48 months
time frame: Baseline and every 6-12 months, over an intervention period of 48 months
description: Scale for grading cognitive function
measure: Change of neuropsychological test battery from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: It includes: Frontal Assessment Battery, Rey's Auditory Verbal Learning Test, Prose Memory, Stroop Color Word Interference Test, Attentive Matrices, Raven's Progressive Matrices, Trial Making Test, designs copying with and without programming models.
measure: Change of Geriatric Depression Scale (GDS) from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: A self-report assessment for identifing depression in the elderly
measure: Change of Short-form Health Survey (SF-36) from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: Assessment of health status
measure: Change of Memory Complaint Questionnaire (MAC-Q) from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: Assessment of subjective memory complaint
measure: Change of Physical Activity Scale for the Elderly (PASE) from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: Assessment of physical activity level in elderly
measure: Change of AAHPERD (American Alliance for Health, Physical Education, Recreation and Dance) fitness test battery from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: Functional fitness assessment
measure: Change of Composite cognitive score (CCS) from baseline to 48 months
time frame: Baseline and every 6 -12 months, over an intervention period of 48 months
description: It is calculated by averaging the standardized scores (Z-score) of all neuropsychological tests, for assessing the overall changes in cognitive performance.
arm group label: Intervention group
arm group type: Experimental
description: Physical exercise
arm group label: Control group
arm group type: Other
description: Posture Education/Unchanged condition
intervention type: Behavioral
intervention name: Intervention group
description: Supervised, multimodal physical activity including aerobic, resistance and stretching exercises
arm group label: Intervention group
intervention type: Behavioral
intervention name: Control group
description: Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education
arm group label: Control group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alfonso Di Costanzo, MD
role: Principal Investigator
affiliation: University of Molise
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Molise
investigator full name: Alfonso Di Costanzo, MD
investigator title: MD, Professor of Neurology
mesh term: Dementia
mesh term: Memory Disorders
mesh term: Cognitive Dysfunction