<?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>IRCT20180314039092N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-11</date_registration>
      <primary_sponsor>research administration of Tehran university (Alborz campus)</primary_sponsor>
      <public_title>The effect of Tai Chi exercise and Glucosamine supplementation on prevention of fall  in the elderly women whit knee osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the effects of Tai Chi exercise and glucosamine supplementation on selected physical factors effective on balance and Falls Efficacy in elderly women with knee osteoarthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30214</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Following to public announcement (banners and flyers) for aging and arthritis conference, the conference was held in Qazvin city, and subjects was drawn from participants meeting our research criteria through a random assignment method (random number table). For each group, the color cards ( green, yellow, and blue card for the Tai Chi, supplement and control groups, respectively) was considered. After examining and confirming the subjects by medical professionals, eligible ones were referred to the project and a color card allocated to each one in a way that only researcher award of allocation process.considering the color of cards, researcher classified subjects into related groups and informed them of conditions and the interferes they would be received.</study_design>
      <phase>3</phase>
      <hc_freetext>Elderly women With Knee  osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group (training group):three sessions a week For three months, doTai Chi exercises(sun style) under the supervision of a physician and researcher. Intervention 2: Intervention group 2: Intervention group 1: this group  consume Glucosamine Sulfate Supplement three times a week for three months, (Health Burst, American Drug) under supervision Dr. Seyed Hassan Niknejad Hasani has a medical system number 107,821 with a physiotherapy and rehabilitation medicine board. Intervention 3: Control group: Control group: The control group did not receive any variables , Tai Chi and glucosamine supplementation during the three-month study period.</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 I do not decide to share data. However,if needed, the information without identifying the names of the people with a series of code is shown.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elham Attari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.33, Shahed Blvd, Vali asr Ave, , Qazvin Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3416616161</zip>
        <telephone>+98 28 3324 8863</telephone>
        <email>elhamattari58@yahoo.com</email>
        <affiliation>Alborz Campus  of Tehran University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elham attari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No33, shahed Ave, valiasr intersection, Qazvin Town</address>
        <city>Qazvin</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3416616161</zip>
        <telephone>+98 28 3324 8863</telephone>
        <email>elhamattari58@yahoo.com</email>
        <affiliation>Alborz Campus  University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>over 60 years of age
Having knee osteoarthritis grade 2 and 3 according to the criteria of kellegeren and Lawrence
Independence in performing daily activities
Not having paralysis in the body part
Ability to answer questionnaire questions</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having  sports activities
having acute cardio-respiratory disease
Earn a score lower than 24 of the Mini Mental State test
They were under treatment for osteoarthritis
Perform knee joint replacement
Taking drugs that effective on balance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First intervention group (training group):three sessions a week For three months, doTai Chi exercises(sun style) under the supervision of a physician and researcher</i_keyword>
      <i_keyword>Intervention group 2: Intervention group 1: this group  consume Glucosamine Sulfate Supplement three times a week for three months, (Health Burst, American Drug) under supervision Dr. Seyed Hassan Niknejad Hasani has a medical system number 107,821 with a physiotherapy and rehabilitation medicine board.</i_keyword>
      <i_keyword>Control group: Control group: The control group did not receive any variables , Tai Chi and glucosamine supplementation during the three-month study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Speed of movement. Timepoint: 10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured. Method of measurement: The speed of movement was measured by using the time taken for a walk distance of 10 meters per person.</prim_outcome>
      <prim_outcome>Static Balance. Timepoint: 10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured. Method of measurement: Static balance was measured by amount of swing when person  standing  30 seconds with open and closed eyes on Iranian scientist balance calculator system.</prim_outcome>
      <prim_outcome>Dynamic Balance. Timepoint: 10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured. Method of measurement: The dynamic balance was measured using the Time Up Go test. ،Time it takesfor a person until  to lift up from the chair to go 3 meters distance and returns to the seat, it is measured.</prim_outcome>
      <prim_outcome>Lower limb strength. Timepoint: 10 days before and 10 days after the three-month training period of Tai Chi and taking glucosamine supplementation were measured. Method of measurement: The strength of the lower limb was measured based on the number of times sitting and rising from the seat for 30 seconds.</prim_outcome>
      <prim_outcome>Flexibility. Timepoint: 10 days before and 10 days after the three-month training sessions of Tai Chi and supplementation of glucosamine were measured. Method of measurement: Flexibility was measured using the Sit and Rich test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body swing. Timepoint: 10 days before and 10 days after the three-month period of interventions. Method of measurement: TUG test.</sec_outcome>
      <sec_outcome>Fall Efficacy. Timepoint: 10 days before and 10 days after the three-month period of interventions. Method of measurement: Using Fall Efficacy ScaleInternational (FES-I) questionnaire.</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>research administration of Tehran university (Alborz campus)</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-05</approval_date>
        <contact_name>Ethics Committee Sabzevar Islamic Azad university</contact_name>
        <contact_address>Dr Siadati Boulevard: Islamic Azad University of Sabzevar Complex sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
