<?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>IRCT20240126060809N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-30</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Determining the effect of two protocols of high-intensity intermittent training (HIIT) and moderate-intensity continuous training (MICT) on aerobic performance, anthropometric indices and ejection fraction in patients with chronic heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effect of two protocols of high-intensity intermittent training (HIIT) and moderate-intensity continuous training (MICT) on aerobic performance, anthropometric indices and ejection fraction in patients with chronic heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75195</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done using computer generated random numbers from 1 to 70. Numbers will be placed in envelopes in the package. Participants with even numbers will be assigned to the HIIT exercise protocol group and odd numbers to the MICT exercise protocol group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Heart Failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the first group of MICT exercise rehabilitation includes 20-60 minutes of progressive aerobic exercise including; Treadmill running, free running, manual ergometer, and stationary bike will receive VO2 reserve (HRR (Heart rate reserve)) starting at 40%–50% and progressing to 70%–80%.If HRmax is unknown, RPE (Rate of Perceived Exertion) is used to guide exercise intensity. Light, RPE less than 12 or equivalent to 40% HRR. A little hard with RPE 12-13 or average with 40-59% HRR. Hard with RPE 14-16 or equivalent to 60-80% HRR. Intervention 2: Intervention group: The second group receives a HIIT rehabilitation session including work intervals of 30 seconds to 4 minutes with a maximum intensity of 85%-90% HRR with rest intervals of 1-3 minutes with an intensity of 50-70%. If HRmax is unknown, RPE (Rate of Perceived Exertion) is used to guide exercise intensity. Light, RPE less than 12 or equivalent to 40% HRR. A little hard with RPE 12-13 or average with 40-59% HRR. Hard with RPE 14-16 or equivalent to 60-80% HRR.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Najmeh Ghorbanian Bahnamiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>3rd floor, No. 97, 6 Allameh Hassanzadeh, 6 Rezvan Alley, Imam Reza St., Amol</address>
        <city>Amol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4713964665</zip>
        <telephone>+98 11 3575 2775</telephone>
        <email>njm.ghorbanian@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zhra Madani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>second floor, unit 4, corner of 3 Kushasang St., Kushasang St., Rodaki St. Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816786501</zip>
        <telephone>+98 11 3360 8570</telephone>
        <email>shd_madani@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 30 to 70 years
sinus rhythm
Agreeing and complying with our study protocol
The possibility of signing an informed consent form</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>People with peripheral vascular disease
Ventricular premature beats or other arrhythmias
Cardiac conduction defects
History of cardiac pacemaker insertion
Significant valvular heart disease
Arterial blood pressure greater than 180/100 mm Hg
Functional limitations (such as physical limitations)
Concurrent participation in another clinical trial</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the first group of MICT exercise rehabilitation includes 20-60 minutes of progressive aerobic exercise including; Treadmill running, free running, manual ergometer, and stationary bike will receive VO2 reserve (HRR (Heart rate reserve)) starting at 40%–50% and progressing to 70%–80%.If HRmax is unknown, RPE (Rate of Perceived Exertion) is used to guide exercise intensity. Light, RPE less than 12 or equivalent to 40% HRR. A little hard with RPE 12-13 or average with 40-59% HRR. Hard with RPE 14-16 or equivalent to 60-80% HRR.</i_keyword>
      <i_keyword>Intervention group: The second group receives a HIIT rehabilitation session including work intervals of 30 seconds to 4 minutes with a maximum intensity of 85%-90% HRR with rest intervals of 1-3 minutes with an intensity of 50-70%. If HRmax is unknown, RPE (Rate of Perceived Exertion) is used to guide exercise intensity. Light, RPE less than 12 or equivalent to 40% HRR. A little hard with RPE 12-13 or average with 40-59% HRR. Hard with RPE 14-16 or equivalent to 60-80% HRR.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Ejection fraction. Timepoint: Before the intervention and at the end of 12 cardiac rehabilitation sessions. Method of measurement: Echocardiography device.</prim_outcome>
      <prim_outcome>Aerobic performance. Timepoint: Before the intervention and at the end of 12 cardiac rehabilitation sessions. Method of measurement: 6-min Walking Test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Left ventricular size. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Echocardiography device.</sec_outcome>
      <sec_outcome>Left atrium size. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Echocardiography device.</sec_outcome>
      <sec_outcome>Left ventricular global strain. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Echocardiography device.</sec_outcome>
      <sec_outcome>Right ventricular function. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Echocardiography device.</sec_outcome>
      <sec_outcome>Body mass index. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Body analyze device.</sec_outcome>
      <sec_outcome>Skeletal muscle mass. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Body analyze device.</sec_outcome>
      <sec_outcome>Body fat mass. Timepoint: Before starting cardiac rehabilitation and at the end of 12 rehabilitation sessions. Method of measurement: Body analyze device.</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-14</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences, Fateme Zahra Hospital</contact_name>
        <contact_address>Serah Joibar, the beginning of Vali Asr Highway, the headquarters of Mazandaran University of Medical Sciences and Health Services Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
