<?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>IRCT20150531022498N32</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of combined exercise training in active elderly men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of a combined training session on cardiorespiratory fitness , motor control , congnitive function , balance , walking performance and postural control in active elderly men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47984</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Forty active elderly were selected as participants in the research process. After the necessary investigations and based on the information of the completed questionnaires, the subjects were divided into two groups of 20 people using a lottery to divide by simple random method.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Active older men.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: combined exercise group for eight weeks, three sessions per week. Aerobic exercise with 50 to 70% intensity of maximum heart rate, 15 to 30 minutes, weight-bearing resistance training, 3 sets of 15 repetitions for 10 to 15 minutes, balance training for 5 to 10 minutes. Intervention 2: Intervention group: This group performs light aerobic exercise three days a week for 8 weeks, including 15 minutes of walking and 10 aerobic movements with 50 to 60% of maximum maximum heart rate.</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 No decision has been made yet.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Safari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>minasafari04@gmail.com</email>
        <affiliation>Azad University, Rasht Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ramin Shabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 2153</telephone>
        <email>shabani_msn@yahoo.com</email>
        <affiliation>Azad University, Rasht Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>60 to 70 years old men
Be healthy based on a health questionnaire and confirmation by a doctor
Regular exercise history
It has a BMI between 20 and 29
Ability to follow instructions by the examiner and complete the questionnaire</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>70 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Tobacco and alcohol consumption
Failure to attend more than two sessions
Having chronic and specific diseases
Lack of health approval by a doctor
Having mental illness and taking psychotropic drugs</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: combined exercise group for eight weeks, three sessions per week. Aerobic exercise with 50 to 70% intensity of maximum heart rate, 15 to 30 minutes, weight-bearing resistance training, 3 sets of 15 repetitions for 10 to 15 minutes, balance training for 5 to 10 minutes.</i_keyword>
      <i_keyword>Intervention group: This group performs light aerobic exercise three days a week for 8 weeks, including 15 minutes of walking and 10 aerobic movements with 50 to 60% of maximum maximum heart rate</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Heart rate. Timepoint: Before and after the intervention. Method of measurement: Record blood pressure and heart rate before and immediately after the rockport test.</prim_outcome>
      <prim_outcome>Pulmonary function. Timepoint: Before and after the intervention. Method of measurement: A spirometer was used to measure the amount of lung variable volume during respiratory maneuvers.</prim_outcome>
      <prim_outcome>Static motor control. Timepoint: Before and after the intervention. Method of measurement: Static motor control  was measured using a stabillometer .</prim_outcome>
      <prim_outcome>Static balance. Timepoint: Before and after the intervention. Method of measurement: Static balance  was measured using a stabillometer .</prim_outcome>
      <prim_outcome>Static postural control. Timepoint: Before and after the intervention. Method of measurement: Static postural control  was measured using a stabillometer .</prim_outcome>
      <prim_outcome>Walking performance. Timepoint: Before and after the intervention. Method of measurement: This test consists of 10 parts. Subjects had to perform a total of 10 items over a distance of 6 meters and a width of 30 centimeters according to the instructions given, which include:1- Walking level, 2- Change in walking speed, 3- Walking with horizontal rotation of the head,4- Walking with vertical rotation of the head, 5- Walking and pelvic rotation, 6- Walking so that it is an obstacle in the middle of the road,7- Walking with a low reliability level, 8- Walking with your eyes closed, 9- Moving backwards, 10- Climbing stairs.</prim_outcome>
      <prim_outcome>Cognitive function. Timepoint: Before and after the intervention. Method of measurement: In this test, 8 cognitive domains were measured through various skills including executive performance, naming, memory, language, abstraction, short-term memory, and awareness of time and place.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: Before and after the intervention. Method of measurement: Using weight, body mass index, waist to hip ratio and fat percent.</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>Azad University, Rasht Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-05-09</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Rasht Branch</contact_name>
        <contact_address>Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
