<?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>IRCT20180627040251N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-08-19</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>Effects of Core Stability Exercises on Balance and Walking in Elderly Fallers</public_title>
      <acronym></acronym>
      <scientific_title>The Effects of Core Stability Exercises on Balance and Walking in Elderly Fallers with Mild Cognitive Impairment: A randomized control trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the initial evaluation, randomization was done using randomization blocks of 4 methods. Patients are randomly assigned to one of two groups through four random blocks. A member of the research team who is not involved in the selection of samples will determine the randomization sequence using an online randomization system (randomizer.org). Participants will be notified of their group allocation with a sealed envelope, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favour of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fall. Condition 2: Abnormalities of gait and mobility. Condition 3: Posture. Condition 4: Mild cognitive impairment. Condition 5: Strength Exercises.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Core stability exercises - Exercises were performed for eight weeks and three sessions per week for the exercise group. The duration of each training session was 40 minutes, and each session included 5 minutes of warm-up and 5 minutes of cooling down. Core stability exercises consist of 3 levels. All exercises are under the supervision of a physiotherapist. In addition, the researcher stands close to the participant and is careful in all stages of training to prevent events such as falling. Exercises started from level 1, which included static contractions in a steady-state, level 2 exercises included static contractions in an unstable environment. Finally, level 3 exercises included dynamic movements in an unstable position.  The exercises used in this protocol, including the specific exercises to stabilize and the muscles of the spine, pelvic lumbar region, and abdomen. Intervention 2: Control group: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.</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 It is not necessary to publish this information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ِDr Seyed sadradin Shojaedin</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33111-15447</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>sa_shojaedin@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hassan Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>33111-15447</zip>
        <telephone>+98 21 2222 8001</telephone>
        <email>Hassan.sadeghi81@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Had a history of falls in the last 6 month
Obtain score less than 24 on the Mini-mental state examination (MMSE) .
Able to walk without an Assistive Device.
60 years of age and older with the ability and mobility to join the group training sessions.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have acute or chronic disease with influence on balance control (e.g., Parkinson’s disease; diabetes or peripheral neuropathy).
Who participated in regular exercise programs in the last 6th month.
Acute vision and hearing problems</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R29.6</hc_code>
      <hc_code>R26</hc_code>
      <hc_code>R29.3</hc_code>
      <hc_code>G31.84</hc_code>
      <hc_code>Y93.B9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Repeated falls</hc_keyword>
      <hc_keyword>Abnormalities of gait and mobility</hc_keyword>
      <hc_keyword>Abnormal posture</hc_keyword>
      <hc_keyword>Mild cognitive impairment, so stated</hc_keyword>
      <hc_keyword>Activity, other involving muscle strengthening exercises</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: Core stability exercises - Exercises were performed for eight weeks and three sessions per week for the exercise group. The duration of each training session was 40 minutes, and each session included 5 minutes of warm-up and 5 minutes of cooling down. Core stability exercises consist of 3 levels. All exercises are under the supervision of a physiotherapist. In addition, the researcher stands close to the participant and is careful in all stages of training to prevent events such as falling. Exercises started from level 1, which included static contractions in a steady-state, level 2 exercises included static contractions in an unstable environment. Finally, level 3 exercises included dynamic movements in an unstable position.  The exercises used in this protocol, including the specific exercises to stabilize and the muscles of the spine, pelvic lumbar region, and abdomen.</i_keyword>
      <i_keyword>Control group: without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional Mobility. Timepoint: Before the exercise program and after exercise program. Method of measurement: Timed Up and Go test (TUG).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static Balance. Timepoint: Before the exercise program and after exercise program. Method of measurement: Single leg Stance test.</sec_outcome>
      <sec_outcome>Walking. Timepoint: Before the exercise program and after exercise program. Method of measurement: 10 Meter walking 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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-15</approval_date>
        <contact_name>Sport Sciences Research Institute (SSRI)</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
