<?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>IRCT20221207056741N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-01</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>The effect of single and dual task balance training on balance dependent factors of older adults recovered from COVID-19</public_title>
      <acronym></acronym>
      <scientific_title>The effect of single and dual task balance training on balance, cognitive function and fear of falling retired recovered from COVID-19</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67400</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Blinding description: All of the participants in this investigation are divided in tow experimental groups and a control group. they will be participated in a per-test, training and post-test in separate days and they will not be in communication with each other. Therefor there would be a one-way blinding.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COVID 19.</hc_freetext>
      <i_freetext>Intervention group: 1- Single task balance exercise 2- Dual task balance training group 3- Control group, In this research, the single task exercise group only practices balance exercises, while the dual task exercise group simultaneously performs cognitive activity at the same time as balance exercise. The control group in this research only participates in the pre-test and post-test..</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 will be presented as results of the articles

When:
One year after publication

To whom:
The users of the data will be determined according to the opinion of the project officials and Baqiyatullah University of Medical Sciences

Conditions:
Only under the supervision of Baqiyatullah University of Medical Sciences

Where to obtain:
Baqiyatullah University of Medical Sciences

How to obtain:
After the completion of the testing process and a month has passed since its end, the applicant can receive the required information by sending an email to the address of Baqiyatullah University. It is obvious that the information will be provided to them at the discretion of Baqiyatullah University.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>hossain shirvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>MollaSadra street,Vanak Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435916471</zip>
        <telephone>021880400600912</telephone>
        <email>shirvani.h2006@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hesam Iranmanesh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 9 Rezvan alley, Rezvan blvd, Kerman, Iran</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7618973741</zip>
        <telephone>+98 34 3281 4885</telephone>
        <email>hesam.iranmanesh@gmail.com</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aging between 60-80
Ability to stand for a minute and walk for 10 for 10 minutes without and aids and stick
Normal vision
Being able to read and write
Being healthy or not having used any balance affecting medicine
Having tested positive in COVID19 and being hospitalized in a recent year
Living in Kerman city
Scoring more than 24 points at Standardized Mini-Mental State Examination</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Progressive neurological condition such as Parkinson disease, or Alzheimer
Existence of cardiovascular disease (myocardial infarction, congestive heart disease, uncontrolled blood pressure, hypotension, decreased heart rate)
Significant visual and auditory impairments
History of depression, anxiety or other mental disorders
Having a history of rheumatic and metabolic diseases such as rheumatoid arthritis, diabetes
Existence of severe deformities of the joints of the lower limbs or trunk, such as severe Kyphosis or scoliosis, severe osteoarthritis of the hip and knee joints.
Having a history of balance disorder and frequent positional dizziness
 Having a history of joint replacement in the lower limb
Consuming alcohol, sedatives or any type of special medicine that affects balance or cognitive status.
High inflammation of lungs up to 40% due to COVID 19</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U09.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post Covid 19 Condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1- Single task balance exercise 2- Dual task balance training group 3- Control group, In this research, the single task exercise group only practices balance exercises, while the dual task exercise group simultaneously performs cognitive activity at the same time as balance exercise. The control group in this research only participates in the pre-test and post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Berg Balance scale to measure functional balance status in elderly people. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: This test consists of 14 sub-tests that will be administered by the examiner and higher scores in this test indicate higher functional balance. To perform this test, very simple devices such as a timer, a ruler, and a step with a height of 18 to 20 cm will be used.</prim_outcome>
      <prim_outcome>People's reaction time in serial reaction time software to measure cognitive performance in elderly people. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: In this test, the person must respond to the stimuli that are presented in a specific and predetermined pattern on the monitor screen as quickly as possible. For the answer, the person must press the desired key of each stimulus on the keyboard. Reaction time refers to the duration of the presentation of the stimulus until the response to it. Obviously, the faster a person responds, it shows the learning of the sequence and the better functioning of the central nervous and cognitive system of the person.</prim_outcome>
      <prim_outcome>Gait speed in Timed Up And Go Test. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: Timed Up And Go test will be used to measure gait speed. In this test, the person has to get up from a chair with a handle with a height of approximately 46 cm and a handle height of 65 cm, walk 3 meters, go around an obstacle, turn around and sit down. The person performs this test in two conditions with and without the cognitive task at the same time.</prim_outcome>
      <prim_outcome>Measuring the psychological variable of fear of falling by Yardley et al.'s (2005) fear of falling scale. Timepoint: In this research, this variable will be taken from people 24 hours before the training phase and 24 hours after the end of the last training session. Method of measurement: This questionnaire contains 16 questions that people fill in two stages at the beginning and at the end of the training protocol. Higher scores in this test indicate greater fear of falling and lower self-efficacy.</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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-25</approval_date>
        <contact_name>Ethics committee of Baqiyatullah University of Medical Sciences</contact_name>
        <contact_address>MollaSadra street, Vanak Square, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
