<?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>IRCT20170114031942N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-27</date_registration>
      <primary_sponsor>Shahroud University of Technology</primary_sponsor>
      <public_title>The effect of step excersice on risk factors related with fall in cognitively impaired older people</public_title>
      <acronym></acronym>
      <scientific_title>The effect of step excersice on risk factors related with fall in cognitively impaired older people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>86</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33677</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To allocate the participants in the research groups, a computerized list of random numbers for assigning random subjects to blocks (2, 4, 6.8) was identified by a statistical consultant using SPSS software. Then, the assignment of the participants is carried out by one of the research team members who are not associated with the 1: 1 assignment ratio within the training and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>mild cognitive impairment older people.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The participants of this group will participate in a 24-week training program, which will be conducted through three 40 minute sessions per week. Step training is performed on the black and white elastic mat with 2.5 meters long, 1 meter wide and  10 rows of squares, 25 cm x 25 centimeters. The ST program consists of a series of forward, backward, sideways and diagonal steps that, with each sequence, increases the complexity of the step training. The program sequence is organized according to six different levels of difficulty: Junior, Basic, Semi Regular, Regular, Senior and Master. Intervention 2: Control group: Control group participants continue their day-to-day activities and do not receive any special 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran avenue, Shahroud, Semnan Province</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ay.naderi@shahroodut.ac.ir</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran Avenue,  Shahroud, Semnan Province</address>
        <city>shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>Ay.naderi@yahoo.com</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>aged over 65 years
Approval of Petersen’s criteria (mild cognitive status test), to detect amnestic multiple-domain MCI
earning a score of 24 or more in Mini-Mental State Examination and less than 26 in the Montreal Cognitive Assessment
Have enough memory to remember the tips and understand the guidelines for participating in the study
Independent Living in Society
Walk without any help (for example, without the help of a cane or walker)
Confirmation of the physician to participate in the study
Sign the informed confirmation form of the participation in the research.</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Institutional Elderly
history of depression, anxiety or other mental disorders (ie, 5 &lt;GDS-15) 
Receiving the drug for cognitive, neurological or musculoskeletal problems (such as a history of cardiovascular disease, Parkinson's disease, lower extremity surgery, significant orthopedic disorders or acute illness)
Visual impairments in spite of glasses correction
Acute or chronic conditions preventing participate in exercise
Regular exercise ≥30 minutes per day and ≥ 3 days per week</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The participants of this group will participate in a 24-week training program, which will be conducted through three 40 minute sessions per week. Step training is performed on the black and white elastic mat with 2.5 meters long, 1 meter wide and  10 rows of squares, 25 cm x 25 centimeters. The ST program consists of a series of forward, backward, sideways and diagonal steps that, with each sequence, increases the complexity of the step training. The program sequence is organized according to six different levels of difficulty: Junior, Basic, Semi Regular, Regular, Senior and Master.</i_keyword>
      <i_keyword>Control group: Control group participants continue their day-to-day activities and do not receive any special intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fall frequency. Timepoint: The frequency of falling during the study is measured monthly. Method of measurement: Fall frequency test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of falling. Timepoint: At the beginning of the study (before the intervention) and 12 and 24 weeks after the start of the step training. Method of measurement: Fall Efficacy Scale International.</sec_outcome>
      <sec_outcome>Static Balance. Timepoint: At the beginning of the study (before the intervention) and 12 and 24 weeks after the start of the step training. Method of measurement: Frailty and Injuries: Cooperative Studies of Intervention Techniques–4.</sec_outcome>
      <sec_outcome>Dynamic balance. Timepoint: At the beginning of the study (before the intervention) and 12 and 24 weeks after the start of the step training. Method of measurement: Dynamic Gait Index.</sec_outcome>
      <sec_outcome>Reaction time. Timepoint: At the beginning of the study (before the intervention) and 12 and 24 weeks after the start of the step training. Method of measurement: Switch Mat.</sec_outcome>
      <sec_outcome>Falling index. Timepoint: At the beginning of the study (before the intervention) and 12 and 24 weeks after the start of the step training. Method of measurement: Physiological Profile Assessment.</sec_outcome>
      <sec_outcome>Executive Performance. Timepoint: At the beginning of the study (before the intervention) and 12 and 24 weeks after the start of the step training. Method of measurement: Stroop Color-Word, A-B part of Trail-Making Test, Digit Symbol Substitution Test.</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>Shahroud University of Technology</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-14</approval_date>
        <contact_name>Ethics committee of Kermansah University of Medical Sciences</contact_name>
        <contact_address>Beheshti Blvd, Kermanshah, Kermanshah Province Kermansah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
