<?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>IRCT20200408046997N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-17</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>Investigating the effect of combined aqua-exercise on health and physical performance of elderly men</public_title>
      <acronym>-</acronym>
      <scientific_title>Investigating the effect of combined aqua-exercise on complete blood count, physical performance, body composition and quality of life of elderly men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72780</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The samples will be assigned to the study groups, i.e., combined Aqua exercise group (A) and control group (B) using the block randomization method. First the size of each block and the number of blocks will be determined. Considering that the total sample size is 40, 10 blocks of 4 will be used and each block will be used for 4 subjects. Using Random Allocate Software random blocks of 4 with (A) and (B) letters will be created, and then the block number will be selected by lottery, and subjects 1 to 4 will be assigned to the combined aqua exercise group (A) or control group (B) based on the order of letters of the block. Rest of the subjects will be assigned to the combined aqua exercise group (A) or control group (B) in a similar manner.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly people.</hc_freetext>
      <i_freetext>Intervention 1: After performing the pretests for both the combined aquatic exercise and control groups, the exercise group will complete the exercise program for 8 weeks (3 sessions pre week/ 60 minutes each session). All exercises will be done in water with the presence a researcher and an aqua exercise specialist. Each training session includes a 10-minute warm-up in the water (stretching movements and various types of walking in the water and a number of combined stretching and jumping exercises), 20 minutes of resistance exercises in the water for large and main muscle groups (strengthening the chest, thighs and arms) using traction and bouncy forces, along with stretching and aerobics exercises in water for 20 minutes (fast walking, jumping and performed combined with stretching movements and jumping to increase the heart rate) and 10 minutes of cooling down (including, light stretching movements and gentle walking in water). Intervention 2: During the study, the control group will have the usual daily physical activities and go through the normal daily lives and will not participate in any regular and purposeful exercise training program.</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 Not knowing the University regulations regarding it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Karim Zadeh Rostami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, opposite Holy shrine of Imam Khomeini, Persian Gulf Expressway, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15875-5794</zip>
        <telephone>+98 21 5121 2456</telephone>
        <email>reza.karimzadeh7619@gmail.com</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Samadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahed University, Opposite the Holly Shrine of Imam Khomeini, Persian Gulf Highway (Tehran-Qom), Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15875-5794</zip>
        <telephone>+98 21 5121 2456</telephone>
        <email>a.samadi@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Males aged 60 to 75
Not having contraindication to do exercise
Not doing regular exercise in past 6 month</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having known cardiovascular disease
having cognitive and metabolic disorder, such as diabetes
Not being able to do exercise because of musculoskeletal limitations</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After performing the pretests for both the combined aquatic exercise and control groups, the exercise group will complete the exercise program for 8 weeks (3 sessions pre week/ 60 minutes each session). All exercises will be done in water with the presence a researcher and an aqua exercise specialist. Each training session includes a 10-minute warm-up in the water (stretching movements and various types of walking in the water and a number of combined stretching and jumping exercises), 20 minutes of resistance exercises in the water for large and main muscle groups (strengthening the chest, thighs and arms) using traction and bouncy forces, along with stretching and aerobics exercises in water for 20 minutes (fast walking, jumping and performed combined with stretching movements and jumping to increase the heart rate) and 10 minutes of cooling down (including, light stretching movements and gentle walking in water).</i_keyword>
      <i_keyword>During the study, the control group will have the usual daily physical activities and go through the normal daily lives and will not participate in any regular and purposeful exercise training program.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complete blood count. Timepoint: Before and after. Method of measurement: Photometric method.</prim_outcome>
      <prim_outcome>Physical performance. Timepoint: Before and after. Method of measurement: senior fitness test.</prim_outcome>
      <prim_outcome>Body composition. Timepoint: Before and after. Method of measurement: Body composition َAnalyzer.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before and after. Method of measurement: Using SF-36 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after. Method of measurement: Sphygmomanometer.</sec_outcome>
      <sec_outcome>Blood oxygen. Timepoint: Before and after. Method of measurement: Oximeter.</sec_outcome>
      <sec_outcome>Lipid profile. Timepoint: Before and after. Method of measurement: Photometric method.</sec_outcome>
      <sec_outcome>Weight. Timepoint: Before and after. Method of measurement: Scale.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before and after. Method of measurement: Scale and stadiometer.</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-26</approval_date>
        <contact_name>Ethics committee of Shahed University</contact_name>
        <contact_address>Shahed University, opposite to the Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
