<?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>IRCT20180514039648N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-25</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Cognitive-Based Occupational Therapy Interventions on The Level of Cognitive Performance of Elderly Women with Mild Cognitive Impairment (MCI)</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Cognitive-Based Occupational Therapy Interventions on The Level of Cognitive Performance of Elderly Women with Mild Cognitive Impairment (MCI) In Shiraz City: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>62</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80618</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the intervention phase in random trials, for sampling the study samples into different groups of control and control groups, randomly divided in this type of trials, a group of people who are members of Farzangan Shiraz Foundation and meet the entry criteria will be selected (Random Allocation) In each care center for the elderly, there is a list of the names of the members in the center with the national code, and each number will be defined as a variable ID number in the software. We will select about 200 members of Farzangan Shiraz Foundation and measure them using the Montreal Cognitive Status Questionnaire (MOCA) and 62 people who meet all the conditions for entering the study will be selected and using the technique Random sampling in such a way that these 31 people will be classified into 2 equal blocks in each block of 31 people between the groups and the final sample will be set.
Random allocation of elderly people referring to the day care center for the elderly with the help of statistical software in intervention and control groups with Efron's randomization algorithm with blocks equal to Efron's P = 0.75 and 500 rotations (chance in the control and intervention groups is done using blinding In this Procedures DOE► Randomization Lists version 15.0.1 with the command CSS-PASS, the study was a blind study so that the elderly are unaware of their group title, Blinding description: Blinding occurs in participants in such a way that they are unaware of the study group allocation and all participants involved in the study assume that all participants have received the intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Mild cognitive impairment.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group: 12 one-hour intervention sessions will be held for the intervention group (31 people) with the aim of increasing the cognitive skills of elderly women. In the intervention group, the Wechsler Memory Inventory and the Wisconsin Card Test along with the Tower of London Test will be administered before the start of the intervention, immediately after the intervention, and 2 months after the end of the intervention. Intervention 2: Control group: Control group: 12 one-hour yoga and exercise class intervention sessions will be conducted for the control group at the Soroush older adults Center. In the control group, the Wechsler Memory Inventory and the Wisconsin Card Test along with the Tower of London Test will be administered before the start of the intervention, immediately after the intervention, and 2 months after the end of the intervention. After completing the intervention package provided to the experimental group, it will also be provided to the control group.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The datasets generated and/or analysed during the current study are available from the authors upon reasonable request and with the permission of SUMS.

When:
Immediately at the time of printing the results

To whom:
Data will be made available to academic researchers upon request.

Conditions:
Allowed with source reference.

Where to obtain:
Scientific supervisor of the study: Dr. Abdolrahim Asadollahi by sending him an official email.

How to obtain:
Upon receiving an email from the applicant and reviewing his/her academic qualifications, data will be shared immediately to the same email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdis Ferasat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Ave.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 921 260 3660</telephone>
        <email>mahdisrb2@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdolrahim Asadollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Ave.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153617790</zip>
        <telephone>+98 912 249 8890</telephone>
        <email>a.asadollahi@hotmail.co.uk</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly women with mild cognitive impairment evaluated with the Mocha test with a score less than 26
Elderly women with memory complaints
Willingness to participate in the study</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having more than one absent session or more in treatment programs
Elderly women who attended the pre-test but did not attend the post-test.
Incomplete completion of questionnaires
Transfer of residence or long-term illness or refusal of treatment and death.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G31. 84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild cognitive impairment of uncertain or unknown etiology</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: 12 one-hour intervention sessions will be held for the intervention group (31 people) with the aim of increasing the cognitive skills of elderly women. In the intervention group, the Wechsler Memory Inventory and the Wisconsin Card Test along with the Tower of London Test will be administered before the start of the intervention, immediately after the intervention, and 2 months after the end of the intervention.</i_keyword>
      <i_keyword>Control group: Control group: 12 one-hour yoga and exercise class intervention sessions will be conducted for the control group at the Soroush older adults Center. In the control group, the Wechsler Memory Inventory and the Wisconsin Card Test along with the Tower of London Test will be administered before the start of the intervention, immediately after the intervention, and 2 months after the end of the intervention. After completing the intervention package provided to the experimental group, it will also be provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Executive Functions. Timepoint: Before the intervention, immediately after the end of the intervention, and two months after the intervention. Method of measurement: Tower of London test.</prim_outcome>
      <prim_outcome>Cognitive flexibility. Timepoint: Before the intervention, immediately after the end of the intervention, and two months after the intervention. Method of measurement: Wisconsin Card Sorting Inspired Task (WCST).</prim_outcome>
      <prim_outcome>Memory. Timepoint: Before the intervention, immediately after the end of the intervention, and two months after the intervention. Method of measurement: Wechsler Memory Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-11</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>School of Health, Razi Ave. Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
