<?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>IRCT20180101038168N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-26</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Comparison of the effect of turning and balance training on motor function and quality of life in the elderly.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effect of two combined turning and balance training protocols on some motor function indicators and quality of life in the elderly.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47351</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation is done using a table of random numbers. To use the random number table, the framework of the statistical community is first specified and according to the two-digit statistical population, two-digit codes are given to the participants. The researcher accidentally starts moving from one point in the table to the left of the table. The point is selected by closing the eye and placing the tip of the pen on the table. Even numbers are considered for intervention group one and Odd numbers are considered for intervention group two.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Elderly. Condition 2: Motor function indicators  in the elderly. Condition 3: Quality of life in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: balance training group - take part in a 60- minute balance training program of 3 sessions per week, lasting for 12 weeks (exercise based on balance challenges in static positions, including different types of standing on one leg, two legs, weight transfer in different directions, on stable and unstable surfaces and dynamic situations include a variety of weight transfer movements with a change in base of support, a variety of walks in different conditions and paths, and a step movement in different directions) to improve balance performance in challenging situations for the elderly, including standing, walking, turning and stair negotiation and preventing falls in these situations. Intervention 2: Second intervention group: turning training group - take part in a 60- minute turning training program of 3 sessions per week, lasting for 12 weeks (exercises based on turning challenges in static positions include standing types with turning component along with rotational weight transfer, and dynamic positions include various types of turning movements at different degrees on hard and soft surfaces with changes in base of support, walking on turning and spiral paths and turning step movements) to improve turning performance in challenging situations for the elderly including standing, walking, turning and stair negotiation, and preventing falls in these situations.</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 Demographic information is available but the names of the participants are not known.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Ghaderian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 18, Masuod deadlock, Ohod Blvd, East Hasht Behesh Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8157957876</zip>
        <telephone>+98 31 3268 8075</telephone>
        <email>mehdighaderiyan67@gmail.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehdi Ghaderian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 18, Masuod deadlock, Ohod Blvd, East Hasht Behesh Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8157957876</zip>
        <telephone>+98 31 3268 8075</telephone>
        <email>mehdighaderiyan67@gmail.com</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having age 60 or older
Lack of regular physical activity
Functional independence and the ability to perform daily life activities</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Mental disorders
Acute heart-respiratory diseases
Acute joint diseases
Hypertension
Paralysis of a part of the body</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R54</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Age-related physical debility</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group: balance training group - take part in a 60- minute balance training program of 3 sessions per week, lasting for 12 weeks (exercise based on balance challenges in static positions, including different types of standing on one leg, two legs, weight transfer in different directions, on stable and unstable surfaces and dynamic situations include a variety of weight transfer movements with a change in base of support, a variety of walks in different conditions and paths, and a step movement in different directions) to improve balance performance in challenging situations for the elderly, including standing, walking, turning and stair negotiation and preventing falls in these situations.</i_keyword>
      <i_keyword>Second intervention group: turning training group - take part in a 60- minute turning training program of 3 sessions per week, lasting for 12 weeks (exercises based on turning challenges in static positions include standing types with turning component along with rotational weight transfer, and dynamic positions include various types of turning movements at different degrees on hard and soft surfaces with changes in base of support, walking on turning and spiral paths and turning step movements) to improve turning performance in challenging situations for the elderly including standing, walking, turning and stair negotiation, and preventing falls in these situations.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Static balance. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Measure the center of pressure excursion using the force plate device.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Measuring the center of mass position in relation to base of support and the average rate of stopping and vertical loading rate using the motion analysis device and force plate while walking.</prim_outcome>
      <prim_outcome>Gait function. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Measurement of joint angular position, center of pressure changes and ground reaction force parameters while walking using motion analysis system and force plate.</prim_outcome>
      <prim_outcome>Turning function. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Measurement of joint angular position , center of pressure changes, coefficient of friction and ground reaction force parameters while turning using motion analysis system and force plate.</prim_outcome>
      <prim_outcome>Stair negotiation function. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Measurement of joint angular position, center of pressure changes and ground reaction force parameters while stepping up and down using motion analysis system and force plate.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Quality of Life Scale (CASP-19).</prim_outcome>
      <prim_outcome>Fear of falling. Timepoint: Measurement at the beginning of the study (before the intervention begins) and after 12 weeks of exercise. Method of measurement: Falls Efficacy Scale-International (FES-I).</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>University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-04</approval_date>
        <contact_name>Ethics committee of University of Isfahan</contact_name>
        <contact_address>University of Isfahan, Azadi Square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
