<?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>IRCT20210615051585N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-29</date_registration>
      <primary_sponsor>Shifa Tameer e Millat University</primary_sponsor>
      <public_title>Effect of tai chi intervention for improving motor skills and executive function in older adults</public_title>
      <acronym></acronym>
      <scientific_title>Effect of tai chi intervention for improving motor skills and executive function in older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>77</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69581</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment using the sealed envelope method will use. According to the sample size, 70 sheets of aluminum paper will be cut properly. This paper will be double the size of the paper. 35 sheets of carbon paper cut into appropriate sizes according to the paper used. A standard-sized square paper will take and mark with (the Tai chi group). In this way, 35 papers will mark with (Control group ). The sheet of paper on which either the tai chi group or the control group will mention will then be folded to fit in the envelope. A sheet of carbon paper will place on top of the folded paper and mark either the tai chi group or the control group facing the envelope, then the sheet of aluminum foil will be wrapped on the carbon paper( with folded paper inside). All the above-prepared papers will place in the envelope (which will utterly opaque) the envelope will then be sealed. in this way, 35 envelopes for the tai chi group and 35 envelopes for the control group will prepare with a total number of 70. These envelopes will then thoroughly shuffle like a deck of cards. The envelopes will then mark with numbers 1-70. Each participant picks the envelope in order from 1-70 and will be allotted to the group( tai chi group or control group) accordingly, Blinding description: Only the researcher doing the study knows which treatment or intervention the participant is receiving until the intervention is complete. It makes results less likely to be biased. For that, People receiving treatment will engage to the same extent, also, therapist who will deliver treatment do so with the same effort and enthusiasm, regardless of whether they are delivering treatment or a control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Old age.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For this group, a series of tai chi exercises will be carried out in smooth pattern. Doing Tai chi exercises in a specific pattern will improve individuals ability to perform coordinated activities, body awareness, mental focus and flexibility. Each training session consist of a 10-minute warm-up, 40 minutes practicing basic Tai Chi forms, and a 10-minute cool-down. These session will last for 6 consecutive weeks for a number of 5 days per week. Intervention 2: Control group: this group will receive a basic protocol of 60 minutes involving 10 minutes warms up 10 minutes of static stretching of major muscle groups , 40 minute aerobic exercises and 10 minutes cool down. These sessions will be given for 6 weeks consecutively for 5 days per week.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to ethical considerations</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Saima Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Rehabilitation Sciences, Park Rd campus Chak shahzad, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 8441751</telephone>
        <email>Saimagul.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Saima Gul</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Rehabilitation Sciences, Park Rd campus Chak shahzad, Islamabad</address>
        <city>Islamabad</city>
        <country1>Pakistan</country1>
        <zip>44000</zip>
        <telephone>+92 51 8441751</telephone>
        <email>Saimagul.ahs@stmu.edu.pk</email>
        <affiliation>Shifa Tameer e Millat University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>male and female of 60 years and above
single leg stance score less than 20 seconds</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>85 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>color blind individuals
bed bound individuals
visually impaired individuals</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R54</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Age-related physical debility</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: For this group, a series of tai chi exercises will be carried out in smooth pattern. Doing Tai chi exercises in a specific pattern will improve individuals ability to perform coordinated activities, body awareness, mental focus and flexibility. Each training session consist of a 10-minute warm-up, 40 minutes practicing basic Tai Chi forms, and a 10-minute cool-down. These session will last for 6 consecutive weeks for a number of 5 days per week.</i_keyword>
      <i_keyword>Control group: this group will receive a basic protocol of 60 minutes involving 10 minutes warms up 10 minutes of static stretching of major muscle groups , 40 minute aerobic exercises and 10 minutes cool down. These sessions will be given for 6 weeks consecutively for 5 days per week.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Motor skills and executive functions. Timepoint: Before intervention and  6 weeks after intervention. Method of measurement: Time up and go test, stroop test, trail making test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance, activities of daily living. Timepoint: Baseline and after intervention. Method of measurement: Single leg stance test, barthel index.</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>Shifa Tameer e Millat University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-04</approval_date>
        <contact_name>institutional review board and ethics committee of shifa international hospital</contact_name>
        <contact_address>shifa international hosptial, pitrus bukhari road, h-8, islamabad. Islamabad Federal Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
