<?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>IRCT20180514039648N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-07</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of balance exercises on women with Frailty syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of short -term Conditional-Equilibrium Exercises on Functional Limitations of  fear of falling  in Aged Women with Frailty Syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-12-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44095</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: The samples were randomly divided into control and experimental groups. The experimental group  then receives training based on short -term Conditional-Equilibrium Exercises on Functional Limitations of  fear of falling. not receive any intervention during the training, Randomization description: The randomly assigned by equal permutation blocks method using PASS 11 (2017) software. Effron method was performed one thousand times and according to this method, despite the randomization of the allocation process, individuals in each block were finally provided with equal number of samples in both control and intervention groups. In randomization, an equal chance is provided for the whole sample to fall into one of two groups. The researcher does not intervene in determining the group for the samples.</study_design>
      <phase>N/A</phase>
      <hc_freetext>frailty syndrom.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The central intervention in this study was a situational-equilibrium short-term training program. The training program was based on the general content of the exercise, which aims to "improve functional limitations due to the fear of falling in elderly women with frailty syndrome using short-term situational-equilibrium exercises." The treatment program used in this study is in accordance with the official and standard protocol of "Prevention and safety techniques in falling for the elderly" (Team, 2014), which actually improves muscle strength, increases coordination and flexibility and maintains a state of stability, stability and They become physically balanced, and the exercises were performed in the supine, posterior, side, four-legged, and standing positions. The exercises are designed to be graded and, at the discretion of the therapist and the physical condition of the elderly, can be made more difficult or easier during sessions or even unchanged. According to Rina's standard studies, Benazar and Diaz will be practiced for a short period of time, for 6 weeks and 2 sessions a week for 1 hour and in groups. Prior to the intervention, short training sessions on fall conditions and compensatory techniques required during the fall, as well as the correct posture of the subjects during the training sessions, the correct angle of the joints and the correct way to walk, sleep and sit. During the sessions, they will be reminded regularly as a reminder. One session will be held to familiarize the participants with how to do the exercises and how to hold the training sessions. Educational media such as PowerPoint presentations, video educational video clips, and educational pamphlets will be used for teaching. Intervention 2: Control group: No special training will be provided for 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:
The data file will be shared in Mendeley's database in the form of spss software version 25.

When:
2020

To whom:
faculty members of schools of health and Rehabilitation , Shiraz University of Medical Sciences

Conditions:
more study

Where to obtain:
Researchers

How to obtain:
Send official email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Abdolrahim Asadollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd.floor,Razi Ave.school of Health , Shiraz University of Medical Sciences shiraz</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1005010010</zip>
        <telephone>+98 71 3725 6216</telephone>
        <email>a_asadollahi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Abdolrahim Asadollahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Health,Shiraz University of Medical Sciences,3rd floor, Razi Ave</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1005010010</zip>
        <telephone>+98 71 3725 6216</telephone>
        <email>a_asadollahi@sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Over 55 years old
Having at least 3 items from the Frailty Index
No orthopedic and neurological disorders
No Severe visual and auditory impairment
Earn at least 22 points on the survey of activities and fear of falling Questionnaire</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The central intervention in this study was a situational-equilibrium short-term training program. The training program was based on the general content of the exercise, which aims to "improve functional limitations due to the fear of falling in elderly women with frailty syndrome using short-term situational-equilibrium exercises." The treatment program used in this study is in accordance with the official and standard protocol of "Prevention and safety techniques in falling for the elderly" (Team, 2014), which actually improves muscle strength, increases coordination and flexibility and maintains a state of stability, stability and They become physically balanced, and the exercises were performed in the supine, posterior, side, four-legged, and standing positions. The exercises are designed to be graded and, at the discretion of the therapist and the physical condition of the elderly, can be made more difficult or easier during sessions or even unchanged. According to Rina's standard studies, Benazar and Diaz will be practiced for a short period of time, for 6 weeks and 2 sessions a week for 1 hour and in groups. Prior to the intervention, short training sessions on fall conditions and compensatory techniques required during the fall, as well as the correct posture of the subjects during the training sessions, the correct angle of the joints and the correct way to walk, sleep and sit. During the sessions, they will be reminded regularly as a reminder. One session will be held to familiarize the participants with how to do the exercises and how to hold the training sessions. Educational media such as PowerPoint presentations, video educational video clips, and educational pamphlets will be used for teaching.</i_keyword>
      <i_keyword>Control group: No special training will be provided for the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Frailty. Timepoint: At the beginning and immediately after the intervention is completed. Method of measurement: FSC,5 Item ,2001.</prim_outcome>
      <prim_outcome>Fear of falling and activity restriction. Timepoint: At the beginning and immediately after the intervention is completed. Method of measurement: The survey of activities and fear of falling in the elderly (SAFE).</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-08</approval_date>
        <contact_name>Ethics committee of Faculty of Rehabilitation Sciences, Shiraz University of Medical Sciences</contact_name>
        <contact_address>Abbeyvard Street 1, Chamran Boulevard,shiraz shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
