<?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>IRCT20180618040132N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-01</date_registration>
      <primary_sponsor>The University of Isfahan</primary_sponsor>
      <public_title>The Effect of balance Exercises Training on Preventing Falling in the Elderly</public_title>
      <acronym></acronym>
      <scientific_title>Effect of perturbation training on kinetic factor, EMG, functional movement tests, quality of life and fear of falling in elderly people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31964</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After considering the criteria of the research, the samples were randomly assigned with the help of a random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>elderly (fall).</hc_freetext>
      <i_freetext>Intervention 1: Control group: No practice and doing everyday activities. Intervention 2: First intervention group: anticipatory postural adjustment training group.  they performed 8 weeks of APA-focused training (catching and throwing a ball) three sessions per week and each session one hour. The exercise protocol included 10 minutes of warm-up, 40 minutes of the main training and 10 minutes to cool-down. Variables such as the number (low/high), distance (near/far), the direction (inside the chest/overhead), the type of catching (ground/air), the weight and type of ball (light/heavy, volleyball, basketball, medicine ball), how to sit (fixed chair, movable chair and Swiss Ball), how to stand (large base of support/small base of support), and walking (slow/fast) during the program were manipulated to increase exercise pressure and exercise variation. Intervention 3: Second intervention group: current balance training group. they performed 8 weeks of  training, three sessions per week and each session one hour. The exercise protocol included 10 minutes of warm-up, 40 minutes of the main training and 10 minutes to cool-down. Variables such as Joints flexibility exercises, muscle strength exercises, balance exercises and walking were modified during the program to increase exercise pressure and exercise variation.</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:
All data can be shared after unrecognizable people.

When:
Start the access period from 1 month after printing results up to 1 year.

To whom:
Only researchers working in academic and scientific institutions can access the data.

Conditions:
Any use for scientific use and observance of ethics is permissible.

Where to obtain:
Faculty of physical education, University of Isfahan, Hamed Arghavani
hamed_arghavani1365@yahoo.com
+98 9359799744

How to obtain:
After filing an application by email or contact, data will be sent within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamed Arghavani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Isfahan, Hezarjerib street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3529 1225</telephone>
        <email>hamed_arghavani1365@yahoo.com</email>
        <affiliation>The University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Arghavani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar jerib Blvd, University of Isfahan, Faculty of physical education, Isfahan.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3529 1225</telephone>
        <email>hamed_arghavani1365@yahoo.com</email>
        <affiliation>University of isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>men aged between 60 to 80 years,
having the ability to walk without help
having the normal or corrected vision and hearing
positive response to the whole question of Physical Activity Readiness Questionnaire</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>having abnormalities in the foot
score of less than 24 out of 30 on Mini-Mental State Examination</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>N/A</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: No practice and doing everyday activities</i_keyword>
      <i_keyword>First intervention group: anticipatory postural adjustment training group.  they performed 8 weeks of APA-focused training (catching and throwing a ball) three sessions per week and each session one hour. The exercise protocol included 10 minutes of warm-up, 40 minutes of the main training and 10 minutes to cool-down. Variables such as the number (low/high), distance (near/far), the direction (inside the chest/overhead), the type of catching (ground/air), the weight and type of ball (light/heavy, volleyball, basketball, medicine ball), how to sit (fixed chair, movable chair and Swiss Ball), how to stand (large base of support/small base of support), and walking (slow/fast) during the program were manipulated to increase exercise pressure and exercise variation.</i_keyword>
      <i_keyword>Second intervention group: current balance training group. they performed 8 weeks of  training, three sessions per week and each session one hour. The exercise protocol included 10 minutes of warm-up, 40 minutes of the main training and 10 minutes to cool-down. Variables such as Joints flexibility exercises, muscle strength exercises, balance exercises and walking were modified during the program to increase exercise pressure and exercise variation.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: First and after 12 weeks of practice. Method of measurement: SF36 survey.</prim_outcome>
      <prim_outcome>Balance confidence. Timepoint: First and after 12 weeks of practice. Method of measurement: Activities-Specific Balance Confidence scale.</prim_outcome>
      <prim_outcome>Center of pressure displacement. Timepoint: First and after 12 weeks of practice. Method of measurement: foot scan system was used.</prim_outcome>
      <prim_outcome>Electromyography. Timepoint: First and after 12 weeks of practice. Method of measurement: ME 6000 Electromyography.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: First and after 12 weeks of practice. Method of measurement: Dynamic balance of subjects was measured by time up and go test.</prim_outcome>
      <prim_outcome>Static balance. Timepoint: First and after 12 weeks of practice. Method of measurement: with functional reach test.</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>The University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-03-07</approval_date>
        <contact_name>Institutional Review Board of Isfahan University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences, Hezarjerib street, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
