<?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>IRCT20230902059332N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-13</date_registration>
      <primary_sponsor>No sponsors</primary_sponsor>
      <public_title>The effect of cognitive stimulation program on the cognitive functions of the elderly with chronic obstructive pulmonary disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of the cognitive stimulation program based on the Improvecog model on the cognitive functions of the elderly with chronic obstructive pulmonary disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>25</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72387</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random assignment of the elderly will be done based on their educational status. The samples will be placed in two groups (intervention (use of cognitive stimulation program) and control group) using stratified random block method (in order to match the groups in terms of education level (sub-diploma, diploma, associate and bachelor) The method of allocating the samples to two groups is that by considering the four educational classes (sub-diploma, diploma, associate and bachelor), 4 classes are formed. Within each class, 4 random blocks are used to assign patients to Two groups A (intervention) and group B (control) will be used. For this purpose, a list of blocks will be written first and numbers will be assigned to them, and the order of these blocks will be randomly determined by Excell software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic obstructive pulmonary disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the intervention group, the cognitive stimulation program based on the cognitive improvement model will be held in 12 sessions, each session lasting 90 minutes, and one session will be held every week. The program of each session will be different from the previous session, which creates motivation and interest in the elderly to continue the treatment. This intervention includes a wide range of interesting cognitive activities such as physical activities, presenting songs and identifying and classifying sounds, talking about childhood and their jobs in youth and adulthood, talking about the taste and value of food, talking about It includes current issues and news, related word games, orientation and classification of objects. Intervention 2: Control group: No intervention.</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 Participants' information may not be published without permission from the hospital.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>:Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>616913439</zip>
        <telephone>+98 917 482 9657</telephone>
        <email>Moradi@ens.uk.ac.ir</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fateme Moradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616913439</zip>
        <telephone>+98 917 482 9657</telephone>
        <email>Moradi@ens.uk.ac.ir</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being 65 to 80 years old
Having a definitive diagnosis of chronic obstructive pulmonary disease by a lung specialist
Literacy in reading and writing
Adequate visual and auditory abilities to complete questionnaires, perform tasks, and cognitive exercises
Adequate speech ability for communication
Adequate motor ability (able to walk without assistance and perform personal tasks)
Regular attendance capability for sessions</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a severe or other chronic physical illness that prevents participation in the study
Concurrent diagnosis of other respiratory diseases
Shortness of breath during the study to the extent that the participant cannot complete the session
Presence of a psychiatric disorder
Use of psychiatric medications
Use of any other psychological intervention during the study
Withdrawal from the study and more than two absences from intervention sessions.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the intervention group, the cognitive stimulation program based on the cognitive improvement model will be held in 12 sessions, each session lasting 90 minutes, and one session will be held every week. The program of each session will be different from the previous session, which creates motivation and interest in the elderly to continue the treatment. This intervention includes a wide range of interesting cognitive activities such as physical activities, presenting songs and identifying and classifying sounds, talking about childhood and their jobs in youth and adulthood, talking about the taste and value of food, talking about It includes current issues and news, related word games, orientation and classification of objects.</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cognitive failures score in Broadbent questionnaire. Timepoint: Measuring cognitive failures before and after the study (pre-test and post-test stage). Method of measurement: Broadbent Cognitive failures Questionnaire.</prim_outcome>
      <prim_outcome>Information processing speed score in digit symbol test. Timepoint: Measuring the information processing speed before and after the study (pre-test and post-test stage). Method of measurement: The Symbol Digit Modalities Test (SDMT).</prim_outcome>
      <prim_outcome>The score in the visuospatial test of corsi block. Timepoint: Measuring visuospatial working memory before and after the study (pre-test and post-test stage). Method of measurement: the visuospatial test of corsi block.</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>No sponsors</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-15</approval_date>
        <contact_name>The Ethics Committee of Shahid Bahonar University of Kerman, Department of Psychology.</contact_name>
        <contact_address>Imam Khomeini Highway, Pajoohesh Square, Shahid Bahonar University of Kerman. Kerman Kerman Ireland</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
