<?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>IRCT20190308042965N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-07-14</date_registration>
      <primary_sponsor>Ferdowsi University of Mashhad</primary_sponsor>
      <public_title>Exercise and Arterial Stiffness</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effects of Aerobic and Resistance Exercise on Arterial Stiffness and Inflammatory Biomarkers in Obese Sedentary Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>28</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39668</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Based on the number of samples, some cards were prepared and half of them were labeled as aerobic and the other half as resistance training and all the cards were placed in a container. Then, each participant was asked to pull out a card and based on he label, participant was placed one of the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Healthy and inactive obese women.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The aerobic exercise included riding a spin bike for 35-50 min per session at an intensity of 50-70% of the maximum heart rate. The workout consisted of three sections: warm-up including static and dynamic stretching (5 min), riding the spin bike (25-40 min), and cool-down (5 min) as stretching moves. The exercise program was performed for 35 min with at an intensity of 50-60% of the maximum heart rate reserve throughout the first and second weeks, followed by 40 min with the intensity of 50-60% during the third and fourth weeks. On the fifth and sixth weeks, the individuals performed the exercise for 45 min at an intensity of 60-70% of the maximum heart rate reserve. Afterward, they completed 50 min of exercise at an intensity of 60-70% during the seventh and eighth weeks. The exercise intensity was controlled by the Polar wrist heart rate monitor throughout the exercise. Intervention 2: Intervention group: The plan for resistance training was designed similar to that of DeVallance et al. (2016). Resistance training encompassed progressive upper and lower body workouts using six sports devices. Warm-up and cool-down were performed in the beginning and at the end of the exercise for 5 min by stretching. In the first session, the subjects were familiarized with the devices and the one repetition maximum (1RM) was measured for the exercises related to the upper and lower extremities. In each session, the upper-body exercises required the use of special devices, including vertical chest press, triceps extension, and biceps curl. In addition, leg curl, leg extension, as well as multi hip exercise were applied for lower-body workouts. The intensity of resistance training increased progressively every 2 weeks as follows: the first and second weeks with 60% of 1RM, the third and fourth weeks with 70% of 1RM, the fifth and sixth weeks with 80% of 1RM, followed by the seventh and eighth weeks with 85% 1RM. The participants were encouraged to complete 8-12 repetitions until they were able to perform the exercises properly on their own. In addition, 30-second and 1-min rests were considered between the sets and devices, respectively. .</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ziba Rahimian Mashhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paradise Daneshgah, Azadi Square, Ferdowsi University of Mashhad, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3870 3338</telephone>
        <email>zi.rahimianmashhad@mail.um.ac.ir</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ziba Rahimian Mashhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Paradise Daneshgah, Azadi Square, Ferdowsi University of Mashhad,Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948974</zip>
        <telephone>+98 51 3870 3338</telephone>
        <email>zi.rahimianmashhad@mail.um.ac.ir</email>
        <affiliation>Ferdowsi University of Mashhad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>26-42 years old
Obese
Woman
Healthy
Sedentary</inclusion_criteria>
      <agemin>26 years</agemin>
      <agemax>42 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Coronary artery disease
Diabetes
Renal failure
Hepatic failure
Thyroid problems
Consumption of any specific medicines
Smoking habit
History of regular exercise in the past six months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.09</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other obesity due to excess calories</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The aerobic exercise included riding a spin bike for 35-50 min per session at an intensity of 50-70% of the maximum heart rate. The workout consisted of three sections: warm-up including static and dynamic stretching (5 min), riding the spin bike (25-40 min), and cool-down (5 min) as stretching moves. The exercise program was performed for 35 min with at an intensity of 50-60% of the maximum heart rate reserve throughout the first and second weeks, followed by 40 min with the intensity of 50-60% during the third and fourth weeks. On the fifth and sixth weeks, the individuals performed the exercise for 45 min at an intensity of 60-70% of the maximum heart rate reserve. Afterward, they completed 50 min of exercise at an intensity of 60-70% during the seventh and eighth weeks. The exercise intensity was controlled by the Polar wrist heart rate monitor throughout the exercise.</i_keyword>
      <i_keyword>Intervention group: The plan for resistance training was designed similar to that of DeVallance et al. (2016). Resistance training encompassed progressive upper and lower body workouts using six sports devices. Warm-up and cool-down were performed in the beginning and at the end of the exercise for 5 min by stretching. In the first session, the subjects were familiarized with the devices and the one repetition maximum (1RM) was measured for the exercises related to the upper and lower extremities. In each session, the upper-body exercises required the use of special devices, including vertical chest press, triceps extension, and biceps curl. In addition, leg curl, leg extension, as well as multi hip exercise were applied for lower-body workouts. The intensity of resistance training increased progressively every 2 weeks as follows: the first and second weeks with 60% of 1RM, the third and fourth weeks with 70% of 1RM, the fifth and sixth weeks with 80% of 1RM, followed by the seventh and eighth weeks with 85% 1RM. The participants were encouraged to complete 8-12 repetitions until they were able to perform the exercises properly on their own. In addition, 30-second and 1-min rests were considered between the sets and devices, respectively. .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Arterial Stiffness. Timepoint: Before the intervention, the middle and end of the protocol. Method of measurement: Digital Barometric Pressure sensor.</prim_outcome>
      <prim_outcome>Interleukine-6. Timepoint: Before the intervention, the middle and end of the protocol. Method of measurement: Blood biochemical test.</prim_outcome>
      <prim_outcome>Interleukine-10. Timepoint: Before the intervention, the middle and end of the protocol. Method of measurement: Blood biochemical test.</prim_outcome>
      <prim_outcome>Vo2max. Timepoint: Before the intervention, the middle and end of the protocol. Method of measurement: Bruce protocol.</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>Ferdowsi University of Mashhad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-01-28</approval_date>
        <contact_name>Ethics Committee in Ferdowsi University of Mashhad</contact_name>
        <contact_address>Room 414- Third Floor - Central Organization - Ferdowsi University of Mashhad - Azadi Square, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
