<?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>IRCT20230124057206N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-04</date_registration>
      <primary_sponsor>shahid beheshty University</primary_sponsor>
      <public_title>The effect of 8-week implementation of a balance exercise program called square stepping on the risk factors of falling in elderly men</public_title>
      <acronym></acronym>
      <scientific_title>Effect of eight weeks of square stepping training on fall risk factors in elderly men: a clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75066</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The samples are selected by simple randomization method. In this randomization method, all the samples have an equal chance to be selected, for this purpose, the samples are placed in the list of the statistical population prepared for this purpose, and a number is assigned to each of them, then the numbers are written on pieces of paper. It is written and folded and placed in a container, then it is removed by a third party as grains and it repeats until we reach the desired number, Blinding description: It is explained to the participants what program they are participating in and for what purpose, but how the results of this study will be reviewed and who the other research groups are and what program they may follow. It is not said to do. The clinical caregiver is the only clinical caregiver, there is no need to fully explain the conditions and the participants and the way of their intervention to him. The same goes for the rest of the roles.</study_design>
      <phase>N/A</phase>
      <hc_freetext>fall risk.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: square stepping exercise, this exercise program consists of walking on a pre-made grid of squares, which can be drawn either on the floor or on a portable thin mat. This grid is divided into 40 squares of 25x25, so the dimensions of the grid are 100x250. Stepping patterns are leveled in the exercise booklet. First, the pattern selected by the instructor is performed, then the participants perform the same algorithm to master. The participants must move from the beginning of the grid and according to the stepping pattern towards the end of the grid. Then, leaving the network, they would go back to the starting point from the right side of it and repeat the patterns.After people have mastered the training pattern, we ask them to raise their heels so that they do not touch the square lines. The pattern is repeated even individually. Then the next pattern is explained. In general, 196 training patterns have been designed based on the level of difficulty and progress in 8 categories (beginner 1 and 2, intermediate 1, 2 and 3 and advanced 1, 2 and 3). This training program lasts 8 weeks, three days a week and each session lasts 60 to 70 minutes. At the beginning of the exercise, about 15 minutes of warming up, then 40 minutes spent on exercise, and then about 15 minutes for cooling down are considered. Intervention 2: Control group: performing daily activities in parallel, this group is asked to refrain from any regular exercise and sports intervention during this period of eight weeks and only engage in daily activities.</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 data file without the name and information of the person, the raw sample of the informed consent form, the clinical study report is given in the text of the thesis.

When:
After the defense of the thesis, up to six months after that

To whom:
All people

Conditions:
Any tampering with the data and misuse and plagiarism of them without mentioning the source is not allowed.

Where to obtain:
data bases

How to obtain:
serch on data bases

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>mohammadjavad nezhadmohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>daneshjoo blvd, velenjak, tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8888888888</zip>
        <telephone>+98 21 0000 0000</telephone>
        <email>m.nezhadmohammadi.sbu.ac@gmail.com</email>
        <affiliation>shahid beheshty University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>zareei mostafa</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>daneshjoo blvd velenjak tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8888888888</zip>
        <telephone>+98 21 0000 0000</telephone>
        <email>zareeimostafa@yahoo.com</email>
        <affiliation>shahid beheshti university of tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly in the age range of 60 to 75 years
not prohibiting medical activity (especially severe imbalance and dementia problems) under the supervision of a doctor
Lack of regular sports activity in the last 6 months
Not having a physical and cognitive prohibition to do exercises
Completing the informed consent form
Willingness to participate in research</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria></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>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: square stepping exercise, this exercise program consists of walking on a pre-made grid of squares, which can be drawn either on the floor or on a portable thin mat. This grid is divided into 40 squares of 25x25, so the dimensions of the grid are 100x250. Stepping patterns are leveled in the exercise booklet. First, the pattern selected by the instructor is performed, then the participants perform the same algorithm to master. The participants must move from the beginning of the grid and according to the stepping pattern towards the end of the grid. Then, leaving the network, they would go back to the starting point from the right side of it and repeat the patterns.After people have mastered the training pattern, we ask them to raise their heels so that they do not touch the square lines. The pattern is repeated even individually. Then the next pattern is explained. In general, 196 training patterns have been designed based on the level of difficulty and progress in 8 categories (beginner 1 and 2, intermediate 1, 2 and 3 and advanced 1, 2 and 3). This training program lasts 8 weeks, three days a week and each session lasts 60 to 70 minutes. At the beginning of the exercise, about 15 minutes of warming up, then 40 minutes spent on exercise, and then about 15 minutes for cooling down are considered.</i_keyword>
      <i_keyword>Control group: performing daily activities in parallel, this group is asked to refrain from any regular exercise and sports intervention during this period of eight weeks and only engage in daily activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fall risk. Timepoint: Before and eight weeks after the intervention. Method of measurement: Biodex device fall risk test.</prim_outcome>
      <prim_outcome>Electromyography of selected muscles. Timepoint: Before and eight weeks after the intervention. Method of measurement: Megawin brand electromyography device.</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>shahid beheshty University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-20</approval_date>
        <contact_name>کارگروه اخلاق در پژوهش پژوهشگاه علوم ورزشی</contact_name>
        <contact_address>No. 3, Fifth Alley, Mir Emad St, Shahid Motahari St,Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
