<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/NCT03771131</url>
  </required_header>
  <id_info>
    <org_study_id>DD</org_study_id>
    <nct_id>NCT03771131</nct_id>
  </id_info>
  <brief_title>A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People</brief_title>
  <official_title>A Group Study on the Effects of a Short Multi-Domain Cognitive Training in Healthy Elderly Italian People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Milano Bicocca</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Milano Bicocca</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>
      Alongside physiological cognitive ageing, nowadays there is an alarming increase in the&#xD;
      incidence of dementia that requires communities to invest in its prevention. The engagement&#xD;
      in cognitively stimulating activities and strong social networks have been identified among&#xD;
      those protective factors promoting successful cognitive ageing. One aspect regarding&#xD;
      cognitive stimulation concerns the relevance of the frequency of an external intervention.&#xD;
      For these reasons, the aim of this study was to evaluate the efficacy of a 3-month&#xD;
      multi-domain cognitive training program, administered once per week in a group of healthy&#xD;
      elderly aged over 60 years old. Their results obtained on a series of neuropsychological&#xD;
      tests, both pre- (t0) and post-training (t1), were compared with those of a passive control&#xD;
      group who did not receive the cognitive training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants were assigned to the experimental or control group based on their time of&#xD;
      application to the program. Both experimental and control group underwent a&#xD;
      neuropsychological assessment to investigate different cognitive domains, before and after&#xD;
      (~3 months) the training program. Based on the scores obtained during the preliminary&#xD;
      neuropsychological assessment, the participants of the experimental training group were&#xD;
      divided into small subgroups (ranging from 8 to 12 subjects) to further address&#xD;
      individualization of training (i.e. level of difficulty of the exercises proposed). The&#xD;
      experimental group attended weekly sessions of the multi-domain cognitive training. Each&#xD;
      session lasted around one hour and the overall duration of the training was of 3 months, for&#xD;
      a total of 13 sessions. To promote improvement transfer to everyday life, some of the&#xD;
      exercises proposed were ecological in their nature, in that, they asked participants to solve&#xD;
      tasks that recalled everyday situations (such as remembering names or road maps).&#xD;
      Furthermore, throughout the training, approximately once every two sessions brief&#xD;
      psycho-educational interventions were provided.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2013</start_date>
  <completion_date type="Actual">January 1, 2015</completion_date>
  <primary_completion_date type="Actual">January 1, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing global cognitive functioning. Cutoff: &lt; 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Forward and Backward Digit and Corsi Span scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing verbal and visuo-spatial short term memory. Cutoff: &lt; 4.26 (Forward Digit Span), &lt; 2.65 (Backward Digit Span), &lt; 3.46 (Forward Corsi Span), &lt; 3.08 (Backward Corsi Span). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Short Story test scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing verbal long term memory. Cutoff: &lt; 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing constructional abilities and visuo-spatial long term memory. Cutoff: &lt; 28.87 (Copy), &lt; 9.46 (Recall). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Semantic and Phonological Verbal Fluency scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing executive functions. Cutoff: &lt; 16 (Phonological), &lt; 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Stroop color and word test scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing inhibitory control. Cutoff: &gt; 36.92 (for Time measure), &gt; 4.24 (for Error measure). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Trail Making test scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing attention. Cutoff: &gt; 93 (TMT A), &gt; 282 (TMT B), &gt; 186 (TMT B-A). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from pre-training in Raven's coloured matrices scores</measure>
    <time_frame>Pre- and post-training (after ~3 months of training)</time_frame>
    <description>Raw score, assessing non-verbal reasoning. Cutoff: &lt; 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean scores in the Post-training questionnaire</measure>
    <time_frame>Post-training (after ~3 months of training)</time_frame>
    <description>Scores assessing both the satisfaction level about the training and the possible impact of the program on participants' everyday activities, mood and socialization. Each question was measured on a 5-point Likert scale (1: most negative score; 5: most positive score).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Age-related Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group receiving the multi-domain cognitive training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Passive control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multi-domain cognitive training</intervention_name>
    <description>Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative anamnesis for neurological and/or psychiatric diseases&#xD;
&#xD;
          -  No suspected cognitive impairment as assessed during the pre-training&#xD;
             neuropsychological testing (&gt;2 pathological scores)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Milan-Bicocca</name>
      <address>
        <city>Milan</city>
        <zip>20126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Milano Bicocca</investigator_affiliation>
    <investigator_full_name>Roberta Daini</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>healthy cognitive ageing</keyword>
  <keyword>multi-domain cognitive training</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>Undecided</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/NCT03771131
org study id: DD
nct id: NCT03771131
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Alongside physiological cognitive ageing, nowadays there is an alarming increase in the
      incidence of dementia that requires communities to invest in its prevention. The engagement
      in cognitively stimulating activities and strong social networks have been identified among
      those protective factors promoting successful cognitive ageing. One aspect regarding
      cognitive stimulation concerns the relevance of the frequency of an external intervention.
      For these reasons, the aim of this study was to evaluate the efficacy of a 3-month
      multi-domain cognitive training program, administered once per week in a group of healthy
      elderly aged over 60 years old. Their results obtained on a series of neuropsychological
      tests, both pre- (t0) and post-training (t1), were compared with those of a passive control
      group who did not receive the cognitive training.
Participants were assigned to the experimental or control group based on their time of
      application to the program. Both experimental and control group underwent a
      neuropsychological assessment to investigate different cognitive domains, before and after
      (~3 months) the training program. Based on the scores obtained during the preliminary
      neuropsychological assessment, the participants of the experimental training group were
      divided into small subgroups (ranging from 8 to 12 subjects) to further address
      individualization of training (i.e. level of difficulty of the exercises proposed). The
      experimental group attended weekly sessions of the multi-domain cognitive training. Each
      session lasted around one hour and the overall duration of the training was of 3 months, for
      a total of 13 sessions. To promote improvement transfer to everyday life, some of the
      exercises proposed were ecological in their nature, in that, they asked participants to solve
      tasks that recalled everyday situations (such as remembering names or road maps).
      Furthermore, throughout the training, approximately once every two sessions brief
      psycho-educational interventions were provided.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mean change from pre-training in Montreal Congnitive Assessment (MoCA) scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing global cognitive functioning. Cutoff: < 17.362. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Forward and Backward Digit and Corsi Span scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing verbal and visuo-spatial short term memory. Cutoff: < 4.26 (Forward Digit Span), < 2.65 (Backward Digit Span), < 3.46 (Forward Corsi Span), < 3.08 (Backward Corsi Span). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Short Story test scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing verbal long term memory. Cutoff: < 7.5. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Copy and Recall of Rey-Osterrieth Complex Figure scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing constructional abilities and visuo-spatial long term memory. Cutoff: < 28.87 (Copy), < 9.46 (Recall). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Semantic and Phonological Verbal Fluency scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing executive functions. Cutoff: < 16 (Phonological), < 24 (Semantic). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Stroop color and word test scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing inhibitory control. Cutoff: > 36.92 (for Time measure), > 4.24 (for Error measure). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Trail Making test scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing attention. Cutoff: > 93 (TMT A), > 282 (TMT B), > 186 (TMT B-A). Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean change from pre-training in Raven's coloured matrices scores
time frame: Pre- and post-training (after ~3 months of training)
description: Raw score, assessing non-verbal reasoning. Cutoff: < 18. Cutoff scores indicate the value above/below which the cognitive performance is considered pathological.
measure: Mean scores in the Post-training questionnaire
time frame: Post-training (after ~3 months of training)
description: Scores assessing both the satisfaction level about the training and the possible impact of the program on participants' everyday activities, mood and socialization. Each question was measured on a 5-point Likert scale (1: most negative score; 5: most positive score).
arm group label: Experimental group
arm group type: Experimental
description: Group receiving the multi-domain cognitive training
arm group label: Control group
arm group type: No Intervention
description: Passive control group
intervention type: Behavioral
intervention name: Multi-domain cognitive training
description: Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)
arm group label: Experimental group
criteria: 
gender: All
minimum age: 60 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Milano Bicocca
investigator full name: Roberta Daini
investigator title: Professor
mesh term: Cognitive Dysfunction
sharing ipd: Undecided