<?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>IRCT20151118025105N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-03-18</date_registration>
      <primary_sponsor>Shiraz University</primary_sponsor>
      <public_title>Comparing the effects of Exergaming with brisk walking in older adults</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of 30 minutes of Exergaming with brisk walking in physiological and psychological measures of older adults</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36733</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Each participant is randomized to an AB or BA group, therefore the participant is used as his or her own control. Participants in the AB group receive intervention A (Brisk Walking) followed by intervention B (Exergaming) and the ones in the BA group receive intervention B (Exergaming) followed by intervention A (Brisk Walking), Blinding description: The outcome assessor and data analyzer, which are two different people are blind to which person has been assigned to which group and they just work with the study population, or look at data as a whole.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ageing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group AB- Brisk walking first and then Exergaming: In this group, the participant will first walk briskly for 30 minutes in a park area. Before the start of intervention, their resting blood pressure will be measured and then their heart rate will be consistently recorded throughout the walking session. Also the rest of research valuables like the Rate of Perceived Exertion Scale and the Physical Activity Enjoyment Scale Questionnaire will be measured/filled after the intervention. After 1 week, these participants will perform the second intervention, which is playing Exergames for 30 minutes. In this session, all of the measurements will be taken just like the previous session. Intervention 2: Intervention group BA- Exergaming first and then brisk walking: In this group, the participant will be first playing Exergames for 30 minutes. Before the start of intervention, their resting blood pressure will be measured and then their heart rate will be consistently recorded throughout the Exergaming session. Also the rest of research valuables like the Rate of Perceived Exertion Scale and the Physical Activity Enjoyment Scale Questionnaire will be measured/filled after the intervention. After 1 week, these participants will perform the second intervention, which is walking briskly for 30 minutes in a park area. In this session, all of the measurements will be taken just like the previous session.</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 The data of the participant alone is useless.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Sobhan Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences , 1st Abiverdi Street ,  Chamran Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>SobhaniS@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Sobhan Sobhani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Rehabilitation Sciences , 1st Abiverdi Street , Chamran Boulevard</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71947-33669</zip>
        <telephone>+98 71 3627 1551</telephone>
        <email>SobhaniS@Sums.ac.ir</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having ≥60 years of age
Being able to walk with or without assistive devices for 10 meters
Obtaining a score &lt;6 (out of 15) in the Geriatric Depression Scale
Obtaining a score &gt;23(out of 30) in the Mini-Mental State Examination
Responding No to all of the 7 questions in the Physical Activity Readiness Questionnaire</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having uncorrected vision, hearing or cardiovascular disorders
Taking medications that could affect balance or orientation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group AB- Brisk walking first and then Exergaming: In this group, the participant will first walk briskly for 30 minutes in a park area. Before the start of intervention, their resting blood pressure will be measured and then their heart rate will be consistently recorded throughout the walking session. Also the rest of research valuables like the Rate of Perceived Exertion Scale and the Physical Activity Enjoyment Scale Questionnaire will be measured/filled after the intervention. After 1 week, these participants will perform the second intervention, which is playing Exergames for 30 minutes. In this session, all of the measurements will be taken just like the previous session.</i_keyword>
      <i_keyword>Intervention group BA- Exergaming first and then brisk walking: In this group, the participant will be first playing Exergames for 30 minutes. Before the start of intervention, their resting blood pressure will be measured and then their heart rate will be consistently recorded throughout the Exergaming session. Also the rest of research valuables like the Rate of Perceived Exertion Scale and the Physical Activity Enjoyment Scale Questionnaire will be measured/filled after the intervention. After 1 week, these participants will perform the second intervention, which is walking briskly for 30 minutes in a park area. In this session, all of the measurements will be taken just like the previous session.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Average heart rate. Timepoint: During the intervention. Method of measurement: Heart rate monitor.</prim_outcome>
      <prim_outcome>Peak Heart Rate. Timepoint: During the Intervention. Method of measurement: Heart Rate Monitor.</prim_outcome>
      <prim_outcome>Rate of Perceived Exertion. Timepoint: Immediately after the Intervention. Method of measurement: 10-Point Rate of Perceived Exertion Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and immediately after the intervention. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Double product. Timepoint: Immediately after the intervention. Method of measurement: Multiplying systolic blood pressure number by heart rate over 1 minute.</sec_outcome>
      <sec_outcome>Time spent in each heart rate zone. Timepoint: Immediately after the intervention. Method of measurement: Polar Flow Training Analysis Tool (Software).</sec_outcome>
      <sec_outcome>Enjoyment score. Timepoint: Immediately after the intervention. Method of measurement: Physical Activity Enjoyment Scale Questionnaire (PACSES).</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>Shiraz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-12-12</approval_date>
        <contact_name>Ethics Committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
