<?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>IRCT20220418054577N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-14</date_registration>
      <primary_sponsor>Private</primary_sponsor>
      <public_title>The effect of 12 weeks of continuous  training and Interval training on oxidative stress and DNA damage in breast cancer survivors</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 12 weeks of continuous  training and Interval training on oxidative stress and DNA damage in breast cancer survivors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63174</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method: Simple Randomization, Randomization Unit: Individual, Randomization Tool: Random Number Table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Medium intensity continuous training: During the research, this group will perform three sessions of moderate intensity continuous training for 12 weeks and a week. All aspects of this study are in line with the basic principles of the Helsinki Declaration. The present study is an applied and quasi-experimental method that is performed in two interventions group and a control group. The statistical population of this study includes 45 postmenopausal women after at least six months of termination of their treatment for breast cancer. After the initial assessments, the subjects are randomly divided into three groups of 15 people with continuous training and interval training and the control group. The subjects of the continuous training are subjected to sports intervention for 12 weeks. Each training session is performed using the Ergometer Monark 894E bicycle for 20-30 minutes and under the full supervision of the instructor and physician. At each training session, subjects' heart rate information is monitored by a Finnish-made Polar heart rate monitor and the exercise pressure perception rate (Borg scale RPE scale 6 to 20) is monitored and recorded regularly throughout the time. Intervention 2: Control group:The control group consists of 15 postmenopausal women who are followed during this period and do not do any sports intervention and only continue their daily activities and routine medical care. Intervention 3: Intervention group: High intensity interval training:During the research, this group will perform three sessions of high-intensity interval training for 12 weeks.All aspects of this study are in accordance with the basic principles of the Declaration of Helsinki. The current research is applied and semi-experimental in two intervention groups and one control group. The statistical population of this research includes 45 menopausal women after at least six months of breast cancer treatment. After the initial evaluations, the subjects are randomly divided into three groups of 15 people: continuous exercise, intermittent exercise group, and control group.Each exercise session is done using an ergometer Monark 894E bicycle for 20-30 minutes under the full supervision of a trainer and doctor. In each training session, the subject's heart rate information is recorded regularly by means of Polar heart rate monitor made in Finland and the level of perception of training pressure (by Borg RPE scale 6 to 20) during the entire monitoring time. The main training in this group is in At first (the first week), there were four training stages (30 seconds of pedaling and 2 active rests) in a row. The number of steps increases every week until it reaches 7 steps in the fourth week (one step was added every week until the fourth week), from the fourth week to the 12th week, the number of steps is maintained at the same number (7 steps).</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:
Patients' personal information is confidential. But access to research methods and information obtained from research is not an obstacle

When:
Access period starts 6 months after the results are published "

To whom:
All students and enthusiasts

Conditions:
To use the data to conduct research in this area

Where to obtain:
Authors of this article: sahabeh_mahdiann@yahoo.com

How to obtain:
By sending an email to the author will cooperate with the applicant at the earliest opportunity

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>parisa pournemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, North Kargar St., Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614418</zip>
        <telephone>+98 21 8835 1730</telephone>
        <email>p.pournemati@ut.ac.ir</email>
        <affiliation>Faculty of Physical Education and Sport Sciences - University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Parisa pournemati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Physical Education and Sport Sciences, University of Tehran, Iran, Tehran, North Kargar St.tehran. iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614418</zip>
        <telephone>1417614418</telephone>
        <email>p.pournemati@ut.ac.ir</email>
        <affiliation>Faculty of Physical Education and Sport Sciences, University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>at least 6 months of complete discontinuation of breast cancer treatment
permission of the physician to participating in the research
women should be on the same levele in terms of health،life ، nutrition ،duration of illness
body mass index shoul be above 25kg/m2.weight of body fat more than 30%
ability to exercise with the approval of an oncologist and cardiologist
menopause</inclusion_criteria>
      <agemin>54 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cardiovascular disease
Diabetes disease
Thyroid disease
Smoking</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasm of breast</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Medium intensity continuous training: During the research, this group will perform three sessions of moderate intensity continuous training for 12 weeks and a week. All aspects of this study are in line with the basic principles of the Helsinki Declaration. The present study is an applied and quasi-experimental method that is performed in two interventions group and a control group. The statistical population of this study includes 45 postmenopausal women after at least six months of termination of their treatment for breast cancer. After the initial assessments, the subjects are randomly divided into three groups of 15 people with continuous training and interval training and the control group. The subjects of the continuous training are subjected to sports intervention for 12 weeks. Each training session is performed using the Ergometer Monark 894E bicycle for 20-30 minutes and under the full supervision of the instructor and physician. At each training session, subjects' heart rate information is monitored by a Finnish-made Polar heart rate monitor and the exercise pressure perception rate (Borg scale RPE scale 6 to 20) is monitored and recorded regularly throughout the time.</i_keyword>
      <i_keyword>Control group:The control group consists of 15 postmenopausal women who are followed during this period and do not do any sports intervention and only continue their daily activities and routine medical care.</i_keyword>
      <i_keyword>Intervention group: High intensity interval training:During the research, this group will perform three sessions of high-intensity interval training for 12 weeks.All aspects of this study are in accordance with the basic principles of the Declaration of Helsinki. The current research is applied and semi-experimental in two intervention groups and one control group. The statistical population of this research includes 45 menopausal women after at least six months of breast cancer treatment. After the initial evaluations, the subjects are randomly divided into three groups of 15 people: continuous exercise, intermittent exercise group, and control group.Each exercise session is done using an ergometer Monark 894E bicycle for 20-30 minutes under the full supervision of a trainer and doctor. In each training session, the subject's heart rate information is recorded regularly by means of Polar heart rate monitor made in Finland and the level of perception of training pressure (by Borg RPE scale 6 to 20) during the entire monitoring time. The main training in this group is in At first (the first week), there were four training stages (30 seconds of pedaling and 2 active rests) in a row. The number of steps increases every week until it reaches 7 steps in the fourth week (one step was added every week until the fourth week), from the fourth week to the 12th week, the number of steps is maintained at the same number (7 steps).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum SOD levels. Timepoint: 48 hours before and after the desired interventions. Method of measurement: Blood sampling using ELISA method.</prim_outcome>
      <prim_outcome>Serum GPX levels. Timepoint: 48 hours before and after the desired interventions. Method of measurement: Blood sampling using ELISA method.</prim_outcome>
      <prim_outcome>Serum TAC levels. Timepoint: 48 hours before and after the desired interventions. Method of measurement: Blood sampling using ELISA method.</prim_outcome>
      <prim_outcome>Serum MDA levels. Timepoint: 48 hours before and after the desired interventions. Method of measurement: Blood sampling using ELISA method.</prim_outcome>
      <prim_outcome>Serum 8-OHdg levels. Timepoint: 48 hours before and after the desired interventions. Method of measurement: Blood sampling using ELISA method.</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>Private</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-12-19</approval_date>
        <contact_name>Ethics Committee of the Institute of Physical Education and Sports Sciences</contact_name>
        <contact_address>No 3, Fifth Alley, Mir Emad St, Ostad Motahhari St, Tehran tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
