<?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>IRCT20200108046058N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-02-02</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The surveying of effect of tai-chi chuan on the balance status</public_title>
      <acronym></acronym>
      <scientific_title>The surveying of effect of tai-chi chuan exercise on the balance status of the elderly men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44932</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be selected from the clients according to the inclusion criteria in an accessible and easy manner and then randomly assigned to the experimental and control groups And a written consent is obtained from them. In addition, random allocation of the elderly to the two groups of experimental and control will be done using quadruple random blocks method. (The first 6 blocks are assigned and numbered 1 to 6. Subsequently these blocks plus duplicates of blocks 1 to 4 Regularly stacked together to achieve 10 blocks &lt;40 cases&gt;).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: tai-chi chuan exercise. Condition 2: balance status.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During a briefing session, research tips for the elderly in the intervention group will be described. After pre-test for all participants, the intervention group in a group under the supervision of a specialist instructor and researcher will do selected Tai Chi Kung exercises (Tai Chi Chuan exercise is a type of traditional Chinese exercise that involves physical activity and cognitive control, performed individually or in groups.The principles of Tai Chi Kung include soft and slow movements and special attention to relaxation) for 10 weeks, 2 sessions per week and 30-40 minutes each session in Kashan akramian Clinic. Each exercise session consists of 5 minutes of warm-up, 20 minutes of Tai Chi exercises and 5 minutes of cool-down. Every workout session in elementary program sessions is 30 minutes and the final sessions will increase to 40 minutes. Intervention 2: Control group: The control group will not receive any intervention from the research team.</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:
Reporting of study findings in paper form and presentation at relevant conferences and congresses

When:
Start of access period 6 months after printing results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Reporting of study findings in paper form and presentation at relevant conferences and congresses

Where to obtain:
Communication with Researcher (Hamid Gholami Alavi)
Contact number: 00989223215093
Email: gholami-h@kaums.ac.ir

How to obtain:
If the request is sent by the applicant, it will finally be answered in about a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Gholami alavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>12, Pudat Martyr Ave, Ayatollah Yasrebi Street, kashan</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8716863856</zip>
        <telephone>+98 31 5522 3010</telephone>
        <email>Gholami-h@kaums.ac.ir</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansour Dianti</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Qotbe Ravandi Blvd, Kashan University of Medical Sciences</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81151-87159</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>Mandianati@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>elderly men over 60 years
Be able to do Tai Chi exercise
Not having a history of brain stroke and other diseases that affect balance
Lack of corrected visual and hearing impairment
Resident of Kashan
Elderly not participating in similar studies
Willingness to cooperate
Lack of physical disability
Earn a score below 25 from the Fullerton scale
Patients who do not take sleeping pills daily</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Withdraw from attendance
Absent more than 2 sessions of workouts
Hospitalization
Acute and severe physical illnesses during the study
Prescription of permanent hypnotic medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: During a briefing session, research tips for the elderly in the intervention group will be described. After pre-test for all participants, the intervention group in a group under the supervision of a specialist instructor and researcher will do selected Tai Chi Kung exercises (Tai Chi Chuan exercise is a type of traditional Chinese exercise that involves physical activity and cognitive control, performed individually or in groups.The principles of Tai Chi Kung include soft and slow movements and special attention to relaxation) for 10 weeks, 2 sessions per week and 30-40 minutes each session in Kashan akramian Clinic. Each exercise session consists of 5 minutes of warm-up, 20 minutes of Tai Chi exercises and 5 minutes of cool-down. Every workout session in elementary program sessions is 30 minutes and the final sessions will increase to 40 minutes.</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention from the research team.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage of people with a Fullerton instrument score above 25. Timepoint: Measurement of balance status at baseline (before intervention) and end of study. Method of measurement: Fullerton Advanced Balance Scale.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-21</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>ayatollah yasrebi street، Alley of Martyr Podat, No. 12 kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
