<?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>IRCT2016011426008N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-07-28</date_registration>
      <primary_sponsor>Kish International Campus University of Tehran</primary_sponsor>
      <public_title>The effect of exercise in women with breast cancer</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trail of effect of exercise (resistance-core stability) on muscle strength, balance and core stability in women with breast cancer and healthy women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-05-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>3</phase>
      <hc_freetext>Breast Cancer.</hc_freetext>
      <i_freetext>Intervention 1: In the supervised resistance intervention group, exercise protocol was consisted of resistance training (upper body, lower body). Supervised intervention was included bench press, shoulder press, rowing, pull down, biceps curl, triceps extension, Leg curl, Leg extension, Leg press, Lange, calf strengthening, abductions and Adduction hip. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down. Intervention 2: In the home-based intervention group resistance, exercise protocol was consisted of resistance training (upper body, lower body). Unsupervised Intervention was included bench press, shoulder press, rowing, pull down, biceps curl, triceps extension, Leg curl, Leg extension, Leg press, Lange, calf strengthening, abductions and Adduction hip. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down. Intervention 3: In the combination exercise, intervention group, combination of selected resistance training and balance and core stability training under the supervision of an experienced that was done. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down. Intervention 4: The patients and healthy control groups had their daily activities and did not participate in any exercise program during the intervention period.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bahare Mahmudieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kish International Campus, University of Tehran, Mirmohanna Boulevard, Kish Island, Iran</address>
        <city>Kish</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>79416-55665</zip>
        <telephone>+98 76 4443 0055</telephone>
        <email>baharemahmudieh@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bahare Mahmudieh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kish International Campus, University of Tehran, Mirmohanna Boulevard, Kish Island, Iran</address>
        <city>Kish</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>79416-55665</zip>
        <telephone>+98 76 4443 0055</telephone>
        <email>baharemahmudieh@ut.ac.ir</email>
        <affiliation>University of Tehran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:  Aged 29 to 60 years; Diagnosed with breast cancer stage I to III; Mastectomy in at least the last 12 months; Course of radiation-therapy and chemotherapy are completed; No new rehabilitation in upper and lower body (6 months before the diagnosis of breast cancer); No any type of breast reconstruction; Without regular exercise or less than 2 sessions training per week in the last 6 months. Exclusion criteria: No participation in the Post-test or no continue exercise program; No participation in two consecutive sessions or 3 non-consecutive sessions; Injury, onset or increased pain during exercise; Disease recurrence.</inclusion_criteria>
      <agemin>29 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C50.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Breast, 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>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the supervised resistance intervention group, exercise protocol was consisted of resistance training (upper body, lower body). Supervised intervention was included bench press, shoulder press, rowing, pull down, biceps curl, triceps extension, Leg curl, Leg extension, Leg press, Lange, calf strengthening, abductions and Adduction hip. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down.</i_keyword>
      <i_keyword>In the home-based intervention group resistance, exercise protocol was consisted of resistance training (upper body, lower body). Unsupervised Intervention was included bench press, shoulder press, rowing, pull down, biceps curl, triceps extension, Leg curl, Leg extension, Leg press, Lange, calf strengthening, abductions and Adduction hip. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down.</i_keyword>
      <i_keyword>In the combination exercise, intervention group, combination of selected resistance training and balance and core stability training under the supervision of an experienced that was done. Intervention was performed for 6 weeks, 3 sessions a week and each session lasts up to 1.5 hours. Each session included 10 minutes warm up and 5 minutes cool down.</i_keyword>
      <i_keyword>The patients and healthy control groups had their daily activities and did not participate in any exercise program during the intervention period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Upper extremity muscle strength. Timepoint: Before and 6 weeks after intervention. Method of measurement: Muscle strength in shoulder abduction, shoulder flexion and shoulder external rotation with hand-held dynamometry (Lafayette Manual Muscle Test System).</prim_outcome>
      <prim_outcome>Central Stability (Trunk Muscle Endurance). Timepoint: Before and 6 weeks after intervention. Method of measurement: Core Stability Tests (Beiring-Sorensen Test, McGill  Test, Trunk Flexion Test).</prim_outcome>
      <prim_outcome>Static balance. Timepoint: Before and 6 weeks after intervention. Method of measurement: Functional tests in Static balance: Single Leg, Balance Error Scoring System.</prim_outcome>
      <prim_outcome>Dynamic balance. Timepoint: Before and 6 weeks after intervention. Method of measurement: Functional tests in dynamic balance: Four Square Step Test, Timed 360° Turn, Timed Up &amp; Go.</prim_outcome>
      <prim_outcome>Lower extremity muscle strength. Timepoint: Before and 6 weeks after intervention. Method of measurement: Muscle strength in hip abduction, hip flexion and knee extension with hand-held dynamometry (Lafayette Manual Muscle Test System).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arm Lymphedema. Timepoint: Before and 6 weeks after intervention. Method of measurement: Forearm circumference measurements.</sec_outcome>
      <sec_outcome>Shoulder girdle function. Timepoint: Before and 6 weeks after intervention. Method of measurement: Disability of arm, shoulder and hand (Dash) Questionare.</sec_outcome>
      <sec_outcome>Fear of falling. Timepoint: Before and 6 weeks after intervention. Method of measurement: Fall Efficacy ScaleInternational (FES-I).</sec_outcome>
      <sec_outcome>Profile of Mood States. Timepoint: Before and 6 weeks after intervention. Method of measurement: Profile of Mood State questionnaire (POMS).</sec_outcome>
      <sec_outcome>Fatigue. Timepoint: Before and 6 weeks after intervention. Method of measurement: Piper questionnaire.</sec_outcome>
      <sec_outcome>Quality of Life. Timepoint: Before and 6 weeks after intervention. Method of measurement: National Medical Center and Beckman Research Institute.</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>Kish International Campus University of Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>University of Tehran</contact_name>
        <contact_address>Kish International Campus, Univesity of Tehran, Mirmohanna Boulevard, Kish Island, Iran kish Island  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
