<?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>IRCT20190228042870N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-04-17</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation the effect of endurance training and MitoQ supplementation on blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation the effect of four weeks endurance training and MitoQ supplementation alone and in combination on serum level of some of microRNAs effective on blood pressure and oxidant, antioxidant, inflammatory and on functional cardiac factors in hypertensive patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/37904</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, participants randomly and on the basis of throwing dice into separate groups to compare different treatments by researchers, Blinding description: The patients and all study personnel were blinded to treatment assignment and lipid measurements. Treatments that take place on the participants are impartial and it is not clear which treatment is the best when it comes to clinical testing.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertension.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Hypertension: People in this study have a systolic blood pressure equal to or greater than 140 mm Hg and a diastolic blood pressure equal to or greater than 90 mm Hg. During the study period, which lasted for 4 weeks, no intervention was performed on They do not accept. Intervention 2: Intervention group: 1); Hypertension group with endurance training: In this group, people with hypertension for 4 weeks (3 times a week), exercise endurance bike with specified strength and depending on the aerobic capacity. Intervention 3: Intervention group: 2) Hypertension group with MitoQ supplemented oral administration: In this group, people with hypertension receive a supplement of oral MitoQ capsules at a dose of 20 mg/day for 4 weeks a day. MitoQ is a mitochondria-targeted antioxidant(Advanced CoQ10 Formula). MitoQ is produced by MitoQ company (Auckland, New Zealand). Intervention 4: Intervention group: 3) Hypertension group with oral administration of placebo: In this group, people with hypertension receive a placebo capsule of MitoQ daily for 4 weeks a day. Intervention 5: Intervention group: 4) Hypertension group with MitoQ supplement supplementation and endurance training: In this group, people with hypertension have a cycling endurance training for 4 weeks in 3 times per week, and at the same time they receive a daily MitoQ capsule of 20 mg per day.  MitoQ is a mitochondria-targeted antioxidant(Advanced CoQ10 Formula). MitoQ is produced by MitoQ company (Auckland, New Zealand). Intervention 6: Intervention group: 5) The group was in hypertension with oral administration of placebo (placebo) and endurance training: In this group, people with hypertension have a cycling endurance training for 4 weeks in 3 times per week, and they receive a single placebo capsule of MitoQ daily for oral administration.</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 Continue the research</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Yaser Masoumi-Ardakani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiology Research Center, Deputy of Research and Technology of Kerman University of Medical Sciences, Jahad Blvd, Ebne Sina Street</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619813159</zip>
        <telephone>+98 34 3223 6839</telephone>
        <email>ymab125@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Yaser Masoumi-Ardakani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Physiology Research Center, Deputy of Research and Technology of Kerman University of Medical Sciences, Jahad Blvd, Ebne Sina Street</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619813159</zip>
        <telephone>+98 34 3223 6839</telephone>
        <email>ymab125@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>systolic blood pressure &gt; 140 mmHg
Diastolic pressure &gt; 90 mmHg</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Liver, kidney, lung, diabetes diseases and certain diseases like cancer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>110-115</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Hypertension: People in this study have a systolic blood pressure equal to or greater than 140 mm Hg and a diastolic blood pressure equal to or greater than 90 mm Hg. During the study period, which lasted for 4 weeks, no intervention was performed on They do not accept.</i_keyword>
      <i_keyword>Intervention group: 1); Hypertension group with endurance training: In this group, people with hypertension for 4 weeks (3 times a week), exercise endurance bike with specified strength and depending on the aerobic capacity.</i_keyword>
      <i_keyword>Intervention group: 2) Hypertension group with MitoQ supplemented oral administration: In this group, people with hypertension receive a supplement of oral MitoQ capsules at a dose of 20 mg/day for 4 weeks a day. MitoQ is a mitochondria-targeted antioxidant(Advanced CoQ10 Formula). MitoQ is produced by MitoQ company (Auckland, New Zealand).</i_keyword>
      <i_keyword>Intervention group: 3) Hypertension group with oral administration of placebo: In this group, people with hypertension receive a placebo capsule of MitoQ daily for 4 weeks a day.</i_keyword>
      <i_keyword>Intervention group: 4) Hypertension group with MitoQ supplement supplementation and endurance training: In this group, people with hypertension have a cycling endurance training for 4 weeks in 3 times per week, and at the same time they receive a daily MitoQ capsule of 20 mg per day.  MitoQ is a mitochondria-targeted antioxidant(Advanced CoQ10 Formula). MitoQ is produced by MitoQ company (Auckland, New Zealand).</i_keyword>
      <i_keyword>Intervention group: 5) The group was in hypertension with oral administration of placebo (placebo) and endurance training: In this group, people with hypertension have a cycling endurance training for 4 weeks in 3 times per week, and they receive a single placebo capsule of MitoQ daily for oral administration.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>MiR-21. Timepoint: At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training. Method of measurement: Real-Time PCR.</prim_outcome>
      <prim_outcome>MiR-27a. Timepoint: At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training. Method of measurement: Real-Time PCR.</prim_outcome>
      <prim_outcome>MiR-126. Timepoint: At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training. Method of measurement: Real-Time PCR.</prim_outcome>
      <prim_outcome>MiR-222. Timepoint: At the beginning of the study (before the intervention) and 28 days after taking the MitoQ supplement or performing endurance training. Method of measurement: Real-Time PCR.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: before the intervention and Days 1, 3, 5, ... and 28th day. Method of measurement: Sphygmomanometer.</prim_outcome>
      <prim_outcome>Percentage of arterial oxygen saturation. Timepoint: Before training, during training, immediately after training and at intervals of 15, 30 and 45 minutes after training. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>HDL-c. Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Oxidized LDL. Timepoint: before the intervention and 28th day. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Cholestrol. Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Triglyceride. Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before training, during training, immediately after training and at intervals of 15, 30 and 45 minutes after training. Method of measurement: Pulse Oximeter.</prim_outcome>
      <prim_outcome>Left Ventricular End-Systolic Diamater. Timepoint: before the intervention and 28th day. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Left Ventricular End-diastolic Diamater. Timepoint: before the intervention and 28th day. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Ejection Fraction. Timepoint: before the intervention and 28th day. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Shortening Fraction. Timepoint: before the intervention and 28th day. Method of measurement: Echocardiography.</prim_outcome>
      <prim_outcome>Superoxide dismutase. Timepoint: before the intervention and 28th day. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Glutathione Peroxidase. Timepoint: before the intervention and 28th day. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Malondialdehyde. Timepoint: before the intervention and 28th day. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Interleukin-6. Timepoint: before the intervention and 28th day. Method of measurement: Elisa kit.</prim_outcome>
      <prim_outcome>Hs-CRP. Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Creatinine. Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Alanine aminotransferase (SGPT). Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase (SGOT). Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</prim_outcome>
      <prim_outcome>Alkaline Phosphatase. Timepoint: before the intervention and Days 14 and 28. Method of measurement: Biochemical autoanalyzer.</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-17</approval_date>
        <contact_name>Research Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Jihad Bolvd.Ebnsina Ave.Kerman,Iran kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
