<?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>IRCT20210815052187N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Different exercises on lipid profile, heart rate and inflammatory indices</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of aerobic, resistance and parallel exercise on lipid profiles, heart rate variability, inflammatory and biochemical indices in male smokers with metabolic syndrome.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74196</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Basic scienece, Randomization description: Limited randomization
Random allocation law, which is one of the limited randomization methods, was used for randomization. This method represents a large block for the entire volume. For this purpose, based on the sample size, which will be 40 people. 10 people were randomly assigned to group A, 10 people to group B, 10 people to group C, and 10 people to group D. Then groups A, B, C and D were placed in a lottery container and then randomly the balls were removed from the container without replacement and the created sequence was recorded.

  Random tool
It included table and ball, lottery container, sealed opaque envelopes.
Block was the unit of individual randomization.

Extension of random assignment
In order to widen random allocation, sealed opaque envelopes with random sequence were used. In this method, based on the sample size of the research, a number of envelopes with aluminum wrappers (in order not to make the contents of the envelopes unclear) were prepared and each of the random sequences created was recorded on a card, and the cards inside the envelopes were in order were placed In order to preserve the random sequence, the outer surface of the envelopes is numbered. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of the eligible participants for the study, one of the envelopes was opened and the assigned group of that participant was revealed.

Implementation of random assignment process
In this section, the supervisor created a random sequence, the student checked the participants based on the criteria for entering and exiting the study and enrolled them in the study, and the advisor divided the participants into 4 groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Endurance training: Twelve weeks will be set as intervals. Four days a week, each session includes 10-15 minutes of warming up and cooling down, the first session is 5 repetitions of 3 minutes of running, with an intensity of 60% of the maximum heart rate with 1 minute of active rest along with stretching and relaxation movements (30-40% of the maximum heart rate) ) will be done. Polar F11 heart rate monitor, made in Finland, will be used to control the intensity. Every week, a 3-minute period will be added to the training and intensity will be designed based on the wave curve to create the conditions and consistency of the effects created. Intervention 2: Intervention group: Resistance exercise: including 15-20 minutes of warm-up and cooling, 35-60 minutes of the main body of the exercise in seven stations, including the boat station, butterfly leg press, knee extension, knee bend, forearm bend (biceps), forearm extension to Shoulder side (triceps), in each station 3 sets, 8-12 repetitions, rest between sets 30 seconds and rest between repetitions 60-90 seconds, the intensity will be 60-80% of a maximum repetition, and this intensity will also be The waveform will be applied. Intervention 3: Intervention group: Combined training: Two days a week, the endurance program similar to the endurance group and two days of the resistance program will be implemented alternately. Intervention 4: Control group: They participate in tests only before and after 12 weeks.</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:
A piece of data that contains information about variables that can be shared.

When:
Available period from 2024

To whom:
Researchers

Conditions:
Statistical analysis on the data is not allowed.

Where to obtain:
Amin Farzaneh Hesari af.hessari@gmail.com

How to obtain:
The purposes and uses of the data should be clearly stated by the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin Farzaneh Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Exercise Physiology, Sari Branch, Islamic Azad University, Farah Abad road</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>+98 11 3317 5333</telephone>
        <email>af.hessari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin Farzaneh Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of exercise physiology, Sari Branch, Islamic Azad University, Farah abad road</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>+98 11 3317 5333</telephone>
        <email>af.hessari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Smokers with a history of at least 3 years
Suffering from metabolic syndrome
has not participated in any regular sports program for at least the last 3 months
Waist circumference greater than or equal to 102 cm
Triglyceride level greater than or equal to 150 mg/dL
HDL less than 40 mg/dL, blood pressure 130/85 mmHg
Fasting blood glucose greater than or equal to 110 mg/dL</inclusion_criteria>
      <agemin>22 years</agemin>
      <agemax>32 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Absence of kidney, heart, and nervous diseases
No history of surgery
Not using hormonal and steroid chemical drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E88.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Metabolic disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Endurance training: Twelve weeks will be set as intervals. Four days a week, each session includes 10-15 minutes of warming up and cooling down, the first session is 5 repetitions of 3 minutes of running, with an intensity of 60% of the maximum heart rate with 1 minute of active rest along with stretching and relaxation movements (30-40% of the maximum heart rate) ) will be done. Polar F11 heart rate monitor, made in Finland, will be used to control the intensity. Every week, a 3-minute period will be added to the training and intensity will be designed based on the wave curve to create the conditions and consistency of the effects created.</i_keyword>
      <i_keyword>Intervention group: Resistance exercise: including 15-20 minutes of warm-up and cooling, 35-60 minutes of the main body of the exercise in seven stations, including the boat station, butterfly leg press, knee extension, knee bend, forearm bend (biceps), forearm extension to Shoulder side (triceps), in each station 3 sets, 8-12 repetitions, rest between sets 30 seconds and rest between repetitions 60-90 seconds, the intensity will be 60-80% of a maximum repetition, and this intensity will also be The waveform will be applied</i_keyword>
      <i_keyword>Intervention group: Combined training: Two days a week, the endurance program similar to the endurance group and two days of the resistance program will be implemented alternately.</i_keyword>
      <i_keyword>Control group: They participate in tests only before and after 12 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lipid profile. Timepoint: Measuring the concentration level of lipid profiles at the beginning of the study (before the start of the intervention) and at the end after 12 weeks of the intervention. Method of measurement: 8 cc of blood will be taken from the subjects from the forearm vein. Measurement of the concentration level of lipid profiles by enzyme method (by Pars Azmoun company).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Heart rate variability. Timepoint: Measurement of resting heart rate at the beginning of the study (before the start of the intervention) and at the end after 12 weeks of the intervention. Method of measurement: Holter monitoring device model VX3 of American DMS company along with Full Option software.</sec_outcome>
      <sec_outcome>Measurement of interleukin 6-8-10. Timepoint: Measuring the level of immunoglobulin A at the beginning of the study (before the start of the intervention) and at the end after 12 weeks of the intervention. Method of measurement: Immunoglobulin A by ELISA method and using high sensitivity kits (0.11 pg) made in Italy.</sec_outcome>
      <sec_outcome>Tumor necrosis factor-alpha. Timepoint: Measurement of tumor necrosis factor-alpha at the beginning of the study (before the start of the intervention) and at the end after 12 weeks of the intervention. Method of measurement: Using the ELISA kit made by Buster America.</sec_outcome>
      <sec_outcome>Measurement of cTnI and cTnT. Timepoint: Measurement of cTnI and cTnT at the beginning of the study (before the start of the intervention) and at the end after 12 weeks of the intervention. Method of measurement: Done by using LIAISON device and advanced Chemiluminescence method.</sec_outcome>
      <sec_outcome>CK-MB measurement. Timepoint: CK-MB measurement at the beginning of the study (before the start of the intervention) and at the end after 12 weeks of the intervention. Method of measurement: Using the Horiba kit in the colorimetry method.</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</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-05</approval_date>
        <contact_name>islamic azad university of sari</contact_name>
        <contact_address>farahabad road km 7, sari, mazandaran sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
