<?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>IRCT2017070534911N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-18</date_registration>
      <primary_sponsor>Vice Chanceller for Research of Guilan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of exercise exercises on heart failure patient</public_title>
      <acronym></acronym>
      <scientific_title>The study of effect of 8 weeks of exercise training on The most common aggravating factors of heart failure patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>76</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26554</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: How to exercise sports interventions In the test group, that is For 8 weeks, 2 times a week for 30 minutes of treadmill, Then, the Arm ergometer first started for 3 minutes and up to 8 weeks to 6 minutes, then 10 minutes of incentive spirometry will be done. In addition, 3 times a week for a 30 minute walking, Then, for 30 minutes, the weight of the hand and foot should be repeated 10-15 times in two sets with 5 minutes of rest between the two sets, After that, for 30 minutes, the theraband (elastic band) is performed at the beginning of low resistance and then with medium resistance. In the exercise with weight and theraband, changes in any organ or repeat exercises, rest was considered  for 2 minutes. Before and after the exercises, they will be warmed and cooled for 10-5 minutes. Intervention 2: Control group: There is no intervention.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 khordad Street- Heshmat Hospital</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 133366906466</telephone>
        <email>gicrc@gums.ac.irfzmahmoodi@yahoo.comfmahmoodi1390@gmail.com</email>
        <affiliation>Guilan Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Mahmoodi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>15 Khordad Street- Heshmat Hospital</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4193713194</zip>
        <telephone>+98 133366906466</telephone>
        <email>gicrc@gums.ac.irfzmahmoodi@yahoo.comfmahmoodi1390@gmail.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:The age range40-70 years; with II, III grade heart failure ; patient with the most important aggravating factors  including kidney, lung, diabetes and hypertension difficulties Exclusion criteria: :Exacerbation of heart failure symptoms; arrhythmia ;  ischemic ; HTN crisis; Psychiatric problem;orthopedic problem; speech problem;  hearing problem</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I50.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Congestive heart disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: How to exercise sports interventions In the test group, that is For 8 weeks, 2 times a week for 30 minutes of treadmill, Then, the Arm ergometer first started for 3 minutes and up to 8 weeks to 6 minutes, then 10 minutes of incentive spirometry will be done. In addition, 3 times a week for a 30 minute walking, Then, for 30 minutes, the weight of the hand and foot should be repeated 10-15 times in two sets with 5 minutes of rest between the two sets, After that, for 30 minutes, the theraband (elastic band) is performed at the beginning of low resistance and then with medium resistance. In the exercise with weight and theraband, changes in any organ or repeat exercises, rest was considered  for 2 minutes. Before and after the exercises, they will be warmed and cooled for 10-5 minutes.</i_keyword>
      <i_keyword>Control group: There is no intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lung volume In the intervention group. Timepoint: Before and after 8 weeks of exercise training. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>Lung Volume In the control group. Timepoint: Before and 8 weeks After the start of the study. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Lung capacity In the intervention group. Timepoint: Before and 8 weeks after exercise training. Method of measurement: spirometry.</prim_outcome>
      <prim_outcome>Function and structure of the heart include: LVEF left ventricular fraction (%), systolic ending volume (ESV) and diastolic end volume (EDV). Timepoint: before and after 8 weeks of exercise training. Method of measurement: Echocardiogaphy.</prim_outcome>
      <prim_outcome>Heart Rate. Timepoint: before and after of 8 week. Method of measurement: Pulseoximeter.</prim_outcome>
      <prim_outcome>Blood Pressure. Timepoint: before and after of 8 weeks of exercise training. Method of measurement: pressure indicator.</prim_outcome>
      <prim_outcome>Cr(Creatine Blood). Timepoint: before and after 8 weeks of exercise training. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Potency function. Timepoint: before and after 8 weeks of exercise training. Method of measurement: 6-minute test.</prim_outcome>
      <prim_outcome>HDL, LDL. Timepoint: before and after 8 weeks of exercise training. Method of measurement: Blood test.</prim_outcome>
      <prim_outcome>BSو HbA1C. Timepoint: before and after 8 weeks of exercise training. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Lung capacity In the controlgroup. Timepoint: before and 8 week After the start of the study. Method of measurement: Spirometry.</prim_outcome>
      <prim_outcome>Blood Pressure in the control group. Timepoint: before and 8 week After the start of the study. Method of measurement: pressure indicator.</prim_outcome>
      <prim_outcome>Cr(cratinine Blood) in the control group. Timepoint: before and 8 week After the start of the study. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Heart rate in the control group. Timepoint: before and 8 week After the start of the study. Method of measurement: pulseoximetry.</prim_outcome>
      <prim_outcome>Potency function in the control group. Timepoint: before and 8 week After the start of the study. Method of measurement: 6 minute test.</prim_outcome>
      <prim_outcome>HDL, LDL Blood in the control group. Timepoint: before and 8 week After the start of the study. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>HbA1C, BS in the control group. Timepoint: before and 8 week After the start of the study. Method of measurement: Blood Test.</prim_outcome>
      <prim_outcome>Function and structure of the heart include: LVEF left ventricular fraction (%), systolic ending volume (ESV) and diastolic end volume (EDV) in the control group. Timepoint: Before and 8 weeks After the start of the study. Method of measurement: EchoCardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cardiac arrhythmia. Timepoint: During the exercise. Method of measurement: manitoring.</sec_outcome>
      <sec_outcome>Ischemia. Timepoint: During the exercise. Method of measurement: manitoring.</sec_outcome>
      <sec_outcome>HTN crisis. Timepoint: By indication symptoms. Method of measurement: pressure indicator.</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>Vice Chanceller for Research of Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-06-17</approval_date>
        <contact_name>Ethics Committee of Guilan University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti freeway Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
