<?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>IRCT20240709062370N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-02-02</date_registration>
      <primary_sponsor>The university of Isfahan</primary_sponsor>
      <public_title>An optimized protocol for reducing risk of fall in older adults</public_title>
      <acronym></acronym>
      <scientific_title>An optimized protocol for reducing risk of fall in older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85672</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Simple randomization method. For this purpose, participants are first listed in alphabetical order, and the numbers one and two are assigned to each participant on the list. The unit of randomization is the individual. Randomization is generated and implemented using Microsoft Excel by combining the SORTBY and ARRAYRAND functions. Using this method, each participant is allocated through simple randomization to either the control group or the OPTIMAL group, and the influence of all relevant and irrelevant variables on group allocation is neutralized through random assignment, Blinding description: Given that the type of exercise, duration, intensity, and implementation conditions are identical in both groups, participants will not be aware of the differences in the instructional cues provided or their role as the main intervention of the study. Accordingly, participants will be blinded to the study objectives and group allocation. In addition, the outcome assessor and the data analyst will be blinded to participants’ group assignments.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fall.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Short stick exercises with motivational and attentional instructions based on Optimal theory; The intervention consists of eight weeks and three sessions per week. Short stick exercises include six consecutive warm-up phases, one-handed stick throwing, two-handed throwing, balance exercises, swinging and releasing the stick, and cool-down exercises. Participants in the Optimal group will receive motivational instructions during exercise, including positive feedback, “You are doing great” and the choice of stick color, as well as attentional instructions, “Pay attention to the color mark on the stick.” Exercises are performed while sitting on a chair and using a light stick (21.5 inches long, one inch in diameter, and 200 grams in weight). Intervention 2: Control group: Exercises completely similar to the experimental group (same number of sessions and duration) but without motivational and attentional instructions based on optimal theory.</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 If there is a request for this, it will be done.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Hamid Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Isfahan, Azadi square, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673444</zip>
        <telephone>+98 31 3793 2577</telephone>
        <email>salehi.hamid@gmail.com</email>
        <affiliation>The university of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hamid Salehi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>The University of Isfahan, Azadi square, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673444</zip>
        <telephone>+98 31 3793 2577</telephone>
        <email>salehi.hamid@gmail.com</email>
        <affiliation>The university of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range: 65 to 80 years
No visual impairments</inclusion_criteria>
      <agemin>75 years</agemin>
      <agemax>85 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Diagnosis of depression
Use of walking aids</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>W01</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fall on same level from slipping, tripping and stumbling</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: Short stick exercises with motivational and attentional instructions based on Optimal theory; The intervention consists of eight weeks and three sessions per week. Short stick exercises include six consecutive warm-up phases, one-handed stick throwing, two-handed throwing, balance exercises, swinging and releasing the stick, and cool-down exercises. Participants in the Optimal group will receive motivational instructions during exercise, including positive feedback, “You are doing great” and the choice of stick color, as well as attentional instructions, “Pay attention to the color mark on the stick.” Exercises are performed while sitting on a chair and using a light stick (21.5 inches long, one inch in diameter, and 200 grams in weight).</i_keyword>
      <i_keyword>Control group: Exercises completely similar to the experimental group (same number of sessions and duration) but without motivational and attentional instructions based on optimal theory.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Postural sway. Timepoint: Pre-test, post-test. Method of measurement: Foot scanner device.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static and dynamic balance. Timepoint: Pre test, Post test. Method of measurement: Timed Up and Go test (TUG).</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: Pre test, Post test. Method of measurement: Older Adults’ Quality of Life Questionnaire.</sec_outcome>
      <sec_outcome>Fear of falling. Timepoint: Pre test, Post test. Method of measurement: Geriatric Fear of Falling Measure.</sec_outcome>
      <sec_outcome>Intrinsic Motivation. Timepoint: Pre test, Post test. Method of measurement: Intrinsic Motivation Questionnaire.</sec_outcome>
      <sec_outcome>Falls Self-Efficacy. Timepoint: Pre test, Post test. Method of measurement: Falls Self-Efficacy Scale.</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>The university of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-16</approval_date>
        <contact_name>Research ethics committees of University of Isfahan</contact_name>
        <contact_address>The university of Isfahan, Hezar Jarib Ave Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
