<?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>IRCT20250415065336N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-08</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Effect of dual training on cathepsin B and mayostatin</public_title>
      <acronym></acronym>
      <scientific_title>The effect of dual-task (Cognitive-Functional) training on the biomarkers Cathepsin B and Myostatin in elderly individuals</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study in the field of sports and health aims to examine the effects of a dual-task (physical-cognitive) training program on cognitive and physical performance in elderly participants, Randomization description: Randomization was performed using block stratified randomization based on age (60–74 and ≥75 years) at the individual level. The random sequence was generated in blocks of four with a 1:1 ratio by an independent statistician using random number software. Allocation concealment was ensured with sequentially numbered, opaque, sealed envelopes (SNOSE), Blinding description: The examiner will be an experienced individual external to the research team, and only the data (with groups labeled as 1 and 2) will be provided to the statistical analyst. Thus, both individuals remain blinded to the study results.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants: 12 individuals (male/female) /"Participants will complete an 8-week dual-task (functional-cognitive) training program consisting of:• Frequency: 2 sessions/week• Duration: 30-50 minutes/session / Component : Functional training: Aerobic, resistance, and balance exercises / Cognitive tasks: Memory recall and arithmetic exercises / Training load will be progressively modified through: Increased session duration Greater movement repetitions / Exercise intensity will be monitored using the Borg RPE scale:• Weeks 1-2: Moderate intensity (RPE 8-10)• Subsequent weeks: Vigorous intensity (RPE 10-14). Intervention 2: Control group :12 participants (male/female) / Control participants will be asked to maintain their normal lifestyle patterns and will not participate in structured exercise. They will complete pre-test and post-tests at the same time as the intervention 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Sadat Zendepour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education, Hesari Street, Hassani Square, Mirdamad Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3311115447</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>fatemehzendehpour@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sadegh Amani Shalmazari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education, Hesari Street, Hassani Square, Mirdamad Boulevard</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3311115447</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>amani_sadegh@khu.ac.ir</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60–80 years
No participation in exercise training or physiotherapy during the intervention
No use of specific sports or medicinal supplements
No history of acute chronic cardiovascular or metabolic diseases
No open surgery in the past 6 months to 1 year</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participant's unwillingness or lack of interest to continue in the study
Physician's recommendation for withdrawal from the study
Non-participation in 3 consecutive training sessions
Non-participation in the post-test</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>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants: 12 individuals (male/female) /"Participants will complete an 8-week dual-task (functional-cognitive) training program consisting of:• Frequency: 2 sessions/week• Duration: 30-50 minutes/session / Component : Functional training: Aerobic, resistance, and balance exercises / Cognitive tasks: Memory recall and arithmetic exercises / Training load will be progressively modified through: Increased session duration Greater movement repetitions / Exercise intensity will be monitored using the Borg RPE scale:• Weeks 1-2: Moderate intensity (RPE 8-10)• Subsequent weeks: Vigorous intensity (RPE 10-14).</i_keyword>
      <i_keyword>Control group :12 participants (male/female) / Control participants will be asked to maintain their normal lifestyle patterns and will not participate in structured exercise. They will complete pre-test and post-tests at the same time as the intervention group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum Cathepsin B level. Timepoint: Pre and Post- Test (48 hours before and after 8 weeks of dual training). Method of measurement: Abcam Human Cathepsin B ELISA Kit.</prim_outcome>
      <prim_outcome>Myostatin level. Timepoint: Pre and Post-test. Method of measurement: ELYZA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive performance. Timepoint: Pre and Post-test (72 hours before and after 8 weeks of dual training). Method of measurement: Stroop test.</sec_outcome>
      <sec_outcome>Functional-cognitive test. Timepoint: Pre and Post-test (72 hours before and after 8 weeks of dual training. Method of measurement: Timed Up and Go test.</sec_outcome>
      <sec_outcome>Aerobic fitness. Timepoint: Pre and Post-test (72 hours before and after 8 weeks of dual training. Method of measurement: 6-minute walk test.</sec_outcome>
      <sec_outcome>Fat profile. Timepoint: Pre and Post-test (48 hours before and after 8 weeks of dual training. Method of measurement: Elyza kit.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-05</approval_date>
        <contact_name>"The Research Ethics Committee of Kharazmi University"</contact_name>
        <contact_address>Kharazmi University No.43 South Mofateh St Tehran, 15719-14911 Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
