<?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>IRCT20180721040545N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-08-07</date_registration>
      <primary_sponsor>Islamic Azad University, Neyshabour Branch</primary_sponsor>
      <public_title>The Effect of Aerobic Exercise on Patients with Heart Failure</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Eight Weeks of Continuous and Periodic Aerobic Exercise on some Adhesive Molecules and Inflammatory Indices in Men with Heart Failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32828</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: After screening, these subjects were randomly assigned to control group (n = 14), continuing aerobic exercise group (n = 14) and periodic aerobic exercise group (n = 14). The randomization method will be performed using the random number table. Considering the numbers from 0 to 14 for the control group, the numbers from 14 to 28 for the continuing aerobic exercise group, numbers 28 to 42 for the periodic aerobic exercise group. The researcher chooses one of the numbers and moves in the preset direction and assigns the number for the relevant group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: This group carries out continuous aerobic exercise. Continuous aerobic exercise program (with intensity of  45-70% of maximum heart rate) for 8 weeks (3 sessions per week and 30-50 minutes each session)will be performed, which is designed using treadmill. At the beginning of each session, 10 min of stretching exercise were performed to warm up, and during the training the subjects were monitored.The intensity of exercise is controlled and recorded using heart rate and ECG then at the end of the training, the subjects will cool down using stretching exercises. Intervention 2: Intervention group 2: In this group, the Periodic aerobic exercise program (with three sessions per week, and a intensity of 45-80% of the maximum heart rate) will be design using treadmill and wheelchair. Subjects have resting period between 5-10 minutes according to individual circumstances. At the beginning of each session, 10 min of stretching exercise were performed to warm up, and during the training the subjects were monitored.The intensity of exercise is controlled and recorded using heart rate and ECG then at the end of the training, the subjects will cool down using stretching exercises. Intervention 3: Control group: The control group will not have any physical activity other than doing routine work.</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:
Data related to the indices (IL-6, TNF-α, hs-CRP, ICAM-1, VCAM-1, E-selectin, P-selectin) will be shared.

When:
From 2019

To whom:
Academic researchers

Conditions:
Use with reference

Where to obtain:
ladan.abrishami@gmail.com

How to obtain:
Maximum one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ladan Hosseni Abrishami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.19, Kosar Ave, Vakil Abad Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177966761</zip>
        <telephone>+98 51 3881 6133</telephone>
        <email>ladan.abrishami@gmail.com</email>
        <affiliation>Islamic Azad University, Neyshabour Branch</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ladan Hosseni Abrishami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19, Kosar 41 Ave., Vakil Abad Blvd.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177966761</zip>
        <telephone>+98 51 3881 6133</telephone>
        <email>ladan.abrishami@gmail.com</email>
        <affiliation>Islamic Azad University, Neyshabour Branch</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men aged 50-60 years old with heart  failure grade 1-3 according to New York Heart Association (NYHA) criteria; have a heart power of less than 45% and in terms of physical fitness; have potential for exercises.</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of heart disease less than 5 years old, having regular exercise regularly during the past six months, and performing other exercises along with the exercises during the study period, patient dissatisfaction with continued participation in the study; exacerbation of symptoms of heart failure; cardiac arrhythmias; cardiac ischemia; high blood pressure crisis; neurological problems; orthopedic problems.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Heart failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: This group carries out continuous aerobic exercise. Continuous aerobic exercise program (with intensity of  45-70% of maximum heart rate) for 8 weeks (3 sessions per week and 30-50 minutes each session)will be performed, which is designed using treadmill. At the beginning of each session, 10 min of stretching exercise were performed to warm up, and during the training the subjects were monitored.The intensity of exercise is controlled and recorded using heart rate and ECG then at the end of the training, the subjects will cool down using stretching exercises.</i_keyword>
      <i_keyword>Intervention group 2: In this group, the Periodic aerobic exercise program (with three sessions per week, and a intensity of 45-80% of the maximum heart rate) will be design using treadmill and wheelchair. Subjects have resting period between 5-10 minutes according to individual circumstances. At the beginning of each session, 10 min of stretching exercise were performed to warm up, and during the training the subjects were monitored.The intensity of exercise is controlled and recorded using heart rate and ECG then at the end of the training, the subjects will cool down using stretching exercises.</i_keyword>
      <i_keyword>Control group: The control group will not have any physical activity other than doing routine work.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum IL-6 level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of IL-6 (pg/ml), Using high-sensitivity ELISA kits.</prim_outcome>
      <prim_outcome>Serum TNF-α level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of TNF-α (pg/ml), Using high-sensitivity ELISA kits.</prim_outcome>
      <prim_outcome>Serum hs-CRP level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of hs-CRP (ml/l), Using high-sensitivity ELISA kits.</prim_outcome>
      <prim_outcome>Serum ICAM-1 level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of ICAM -1 (ng/ml), Using high-sensitivity ELISA kits.</prim_outcome>
      <prim_outcome>Serum VCAM-1 level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of VCAM -1 (ng/ml), Using high-sensitivity ELISA kits.</prim_outcome>
      <prim_outcome>Serum E-selectin level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of E-selectin (ng/ml), Using high-sensitivity ELISA kits.</prim_outcome>
      <prim_outcome>Serum P-selectin level. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Serum concentrations of P-selectin (ng/ml), Using high-sensitivity ELISA kits.</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>Islamic Azad University, Neyshabour Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-12</approval_date>
        <contact_name>Sport Sciences Research Institute of Iran</contact_name>
        <contact_address>No. 3, 5th Alley, Mir Emad Ave. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
