<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20161204031227N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-09</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The efficacy of cognitive training intervention on cognitive functions of the older adults with mild cognitive impairment</public_title>
      <acronym></acronym>
      <scientific_title>The effects of attention and working memory-based cognitive intervention on behavioral and neurological evidences of cognitive functions in older adults with mild cognitive impairment</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30675</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: In this study, the patients were allocated to the intervention and control groups using balanced blocked randomization method. 4 blocks of size 8 with equal proportion of patients assigned to each group (intervention group A, and control group B) were used (i.e., 16 patients in each group). Assignment of individuals to these two groups was done by the laboratory secretary who was unaware of the selected codes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild cognitive impairment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the Intervention group, After the evaluation session (using cognitive function evaluation tests) and recording of Event-Related Potentials (ERPs)  participants were trained using Attentive Rehabilitation of Attention and Memory app (ARAM)  in 10 sessions of 45 minutes twice a week and then re-evaluated in the twelfth session. The ARAM is a computerized cognitive rehabilitation program with different tasks for training attention and working memory. The program consisted of 10 graded progressive tasks. All tasks had 10 levels and participants could shift to the higher level after gaining 80 percent of score in each level. Intervention 2: Control group: Participants assigned to the control group did not receive any intervention and were on the waiting list and could receive cognitive intervention after a 3-month follow-up period.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdieh Esmaeili Tarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar Ave., Danshjou Blvd., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 8876 1695</telephone>
        <email>mah.esmaeili@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdieh Esmaeili Tarzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Koodakyar ave., Daneshjou Blvd., Velenjak</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۷۱</zip>
        <telephone>+98 21 8876 1695</telephone>
        <email>mah.esmaeili@uswr.ac.ir</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Monolingual Persian-speaking elderly people over 60 years old with education higher than elementary level
Memory complaint by the patient or a close relative
Objective Memory impairment in Rey Auditory Verbal Learning Test  (1.5 SDs below the age-matched and education-matched norms)
Independence in activities of daily living and complex activities of life
Normal global cognitive function (Mini-Mental Status Examination score &gt; 22 )
No evidence of dementia
No depression (Geriatric Depression Scale score &lt; 5)</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>100 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of a variety of  neurological, medical and psychiatric disease including a history of stroke in the last 12 months, cardiovascular disease, schizophrenia, personality disorder, and bipolar disorder
History of substance abuse
Unmodified sensory impairment and hand mobility impairment
History of participating in cognitive intervention programs in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G31.84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild cognitive impairment, so stated</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the Intervention group, After the evaluation session (using cognitive function evaluation tests) and recording of Event-Related Potentials (ERPs)  participants were trained using Attentive Rehabilitation of Attention and Memory app (ARAM)  in 10 sessions of 45 minutes twice a week and then re-evaluated in the twelfth session. The ARAM is a computerized cognitive rehabilitation program with different tasks for training attention and working memory. The program consisted of 10 graded progressive tasks. All tasks had 10 levels and participants could shift to the higher level after gaining 80 percent of score in each level.</i_keyword>
      <i_keyword>Control group: Participants assigned to the control group did not receive any intervention and were on the waiting list and could receive cognitive intervention after a 3-month follow-up period</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Selective attention. Timepoint: Before intervention, immediately after 12 sessions of intervention and 3 months later. Method of measurement: Attention Network Test (ANT).</prim_outcome>
      <prim_outcome>Working memory. Timepoint: Before intervention, immediately after 12 sessions of intervention and 3 months later. Method of measurement: N-back test.</prim_outcome>
      <prim_outcome>Amplitude of N100 component of event-related potentials. Timepoint: Before intervention and immediately after 12 sessions of intervention. Method of measurement: Event-related potentials were recorded using Mitsar amplifier from 32 scalp electrodes during the attention network test.</prim_outcome>
      <prim_outcome>Latency of N100 component of event-related potentials. Timepoint: Before intervention and immediately after 12 sessions of intervention. Method of measurement: Event-related potentials were recorded using Mitsar amplifier  from 32 scalp electrodes during the attention network test.</prim_outcome>
      <prim_outcome>Amplitude of P300 component of event-related potentials. Timepoint: Before intervention and immediately after 12 sessions of intervention. Method of measurement: Event-related potentials were recorded using Mitsar amplifier  from 32 scalp electrodes during the attention network test.</prim_outcome>
      <prim_outcome>Latency of P300 component of event-related potentials. Timepoint: Before intervention and immediately after 12 sessions of intervention. Method of measurement: Event-related potentials were recorded using Mitsar amplifier  from 32 scalp electrodes during the attention network test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Episodic memory score. Timepoint: Before intervention, Immediately after 12 sessions of intervention and 3 months later. Method of measurement: Rey Auditory Verbal Learning Test (RAVLT).</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-10-09</approval_date>
        <contact_name>Ethics committee of University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Koodakyar Ave, Daneshjou Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
