<?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>IRCT20180730040644N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-15</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Effect of exercise on balance status and quality of life among sample of Iranian elderly in Shiraz, south of IRAN, 2017</public_title>
      <acronym></acronym>
      <scientific_title>Effect of exercise on balance status and quality of life among sample of Iranian elderly in Shiraz, south of IRAN, 2017</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33024</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Initially, the clients referring to two main daily care ageing centers were randomly (via coin flipping) assigned to the experimental and control groups in order to prevent data transmission between the participants in both groups. A total of 60 older people (30 individuals from each center) were selected using the goal-based approach from the clients participating in the educational programs of these two centers.</study_design>
      <phase>2</phase>
      <hc_freetext>Disorders of vestibular function Fall in the elderly.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Conducting training courses that include Cawthorne Cooksey (to improve the Vestibular system) and deep-seated strengthening exercises (including tensile and strength exercises). Intervention 2: Control group: After the intervention in the intervention group, a training session entitled "Equal Exercise Exercise" was provided to the control group.</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:
Only final analysis and data file initialization

When:
Time to print the article up to a year later

To whom:
All researchers

Conditions:
There is no manipulation in the data

Where to obtain:
Send a request by email, if not answered, phone call

How to obtain:
The requested time is about a week after the request is sent

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Bahadori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Blvd. School of Public Health</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7756245321</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>bahadori_farzaneh@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad-Hossein Kaveh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Blvd. School of Public Health</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>77415724120</zip>
        <telephone>+98 71 3725 1001</telephone>
        <email>kaveh@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age (60- 74 years)
basic literacy (ability to read and write),
history of falling over the past 6-12 months
positive Romberg sign
obtaining minimum score 24 in the mini-mental state examination (MMSE)
obtaining minimum score 21in Berg Balance Scale (BBS)
lack of visual impairment
lack of neck disability
non-use of ambulatory assistive devices (AAD)
lack of cognitive impairment and lack of orthopedic and neural impairments</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>74 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue cooperation
incidence of musculoskeletal disorders requiring the use of ambulatory assistive devices or needing treatment.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>H81.8X1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other disorders of vestibular function, right ear</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Conducting training courses that include Cawthorne Cooksey (to improve the Vestibular system) and deep-seated strengthening exercises (including tensile and strength exercises)</i_keyword>
      <i_keyword>Control group: After the intervention in the intervention group, a training session entitled "Equal Exercise Exercise" was provided to the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Effect of Balanced Exercise Training to Improve Balance and Quality of Life in the Elderly. Timepoint: At the beginning of the intervention (before the study began) and immediately after the completion of the study and 2 months after the end of the study. Method of measurement: VNG, BBS.DHI.FES-I,Romberg,Leipad Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To determine and compare the effect of equilibrium training on improving balance and improving the quality of life before and after intervention in two groups of test and control. Timepoint: At the beginning of the study (before the start of the study), immediately after the end of the intervention and 2 months after the last training sessions. Method of measurement: assess the effect of equilibrium training on improving balance (BBS and Roemberg questionnaires) and quality of life (Leipad).</sec_outcome>
      <sec_outcome>Evaluating the effect of equilibrium exercise training on reducing the number of falls in the elderly. Timepoint: At the beginning of the study (before the start of the study), immediately after the end of the intervention and 2 months after the last training sessions. Method of measurement: Evaluating the effect of equilibrium exercise training on reducing the frequency of falls (taking patient records and performing BBS and Römberg tests).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-15</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand Street, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
