<?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>IRCT20230415057913N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-08</date_registration>
      <primary_sponsor>Kharazmi university</primary_sponsor>
      <public_title>The Comparison between the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison between the effect of online and face to face resistance training with manual therapy and mobilization on pain, range of motion, lymphedema, depression, body image and shoulder function in breast cancer survivors.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69786</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this thesis, 42 participants will be recruited and They randomly assigned  into  a control group and two experimental group then, for randomization assignment, coding boxes with random order will be used so that, their size and forms are similar. This process is individually and sealed envelope will be used to randomization so that one number is assigned to a person. Number one will be assigned to resistance training +manual therapy group, number two will be assigned to mobilization group ,and number three will be assigned to control group, Blinding description: In this research, participants will be divided into two experimental groups and a control group. At first, They will be informed about research process generally But, They will not informed about research details such as; objectives. In exert phases, the first and second intervention group will be separated then others. Data analysis will be implemented by statistic data analysis specialist so that he/she will be received statistical data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Women who is survived from breast cancer.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this study, the First intervention group (resistance training + manual therapy) will be executed 6 weeks and 3 sessions per week for 60 min integrated online and in person training. The researcher 1 session will be assigned 1 session to in person training and 2 sessions will be assigned to online training. In this thesis, resistance training will be executed by ACSM guideline included flexors, abductors and external rotators of upper body muscles strengthening. Warm up will be performed for 5 min after and before of training. Training in first and second week will be performed by 8 to 12 repetitions with 2 sets, training in third and fourth week by 8 to 12 repetitions with 3 sets and eventually, fifth and sixth week by 8 to 12 repetitions with 4 sets. Intervention 2: Intervention group: Second intervention group (manual therapy) will be executed 6 weeks mobilization with Dr. Dias protocol for scapula and shoulder joint. Thus, for prevention of lymphedema in breast, thorax anf other portions of included upper limb body, PNF and scar tissue massage will be executed orderly assist and passive movement and then, active and assist active movement with patients education. Intervention 3: Control group: the control group will not bee do any intervention.</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:
only a part of data as a mean is shard with a paper.

When:
September 2023

To whom:
The informatin is confidentional and available for all as a papar

Conditions:
the informatin is confidentional and available for all as a papar

Where to obtain:
Fereshteh ghorbani

How to obtain:
2 months later of publish, data will be sent by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fereshteh Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baran Alley, Vahdat St, Sheikh Ahmed Ansari  St, Gerash City, Fars United, Iran.</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441763684</zip>
        <telephone>+98 71 5244 0054</telephone>
        <email>alifreshfrifit@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fereshteh Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Baran Alley, Vahdat St, Sheikh Ahmed Ansari St, Gerash City. Fars United, Iran.</address>
        <city>Gerash</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7441763684</zip>
        <telephone>+98 71 5244 0054</telephone>
        <email>alifreshfrifit@gmail.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>•	Women  survived from breast cancer in 30 to 50 age.
•	Lack of cardiovascular disease.
•	6 to 12 month past their surgery, Chemotherapy and Radiotherapy.</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>•	Smoking and alcohol usage.
•	Disease recurrent and presence of injury during intervention process.
•	2 consecutive sessions or 3 interval session absence in training process.
•	Lack of intention to taking part in thesis process.</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, the First intervention group (resistance training + manual therapy) will be executed 6 weeks and 3 sessions per week for 60 min integrated online and in person training. The researcher 1 session will be assigned 1 session to in person training and 2 sessions will be assigned to online training. In this thesis, resistance training will be executed by ACSM guideline included flexors, abductors and external rotators of upper body muscles strengthening. Warm up will be performed for 5 min after and before of training. Training in first and second week will be performed by 8 to 12 repetitions with 2 sets, training in third and fourth week by 8 to 12 repetitions with 3 sets and eventually, fifth and sixth week by 8 to 12 repetitions with 4 sets.</i_keyword>
      <i_keyword>Intervention group: Second intervention group (manual therapy) will be executed 6 weeks mobilization with Dr. Dias protocol for scapula and shoulder joint. Thus, for prevention of lymphedema in breast, thorax anf other portions of included upper limb body, PNF and scar tissue massage will be executed orderly assist and passive movement and then, active and assist active movement with patients education.</i_keyword>
      <i_keyword>Control group: the control group will not bee do any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Pre and post test. Method of measurement: Visual Analog Scale.</prim_outcome>
      <prim_outcome>Range of Motion. Timepoint: Pre and post test. Method of measurement: Goniometer.</prim_outcome>
      <prim_outcome>Lymphedema. Timepoint: Pre and post test. Method of measurement: Lymphedema Volume meter.</prim_outcome>
      <prim_outcome>Depression. Timepoint: Pre and post test. Method of measurement: Depression Test.</prim_outcome>
      <prim_outcome>Body Image. Timepoint: Pre and post test. Method of measurement: Body Image Questionnaire.</prim_outcome>
      <prim_outcome>Shoulder function. Timepoint: Pre and post test. Method of measurement: Y Balance tes.</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>Kharazmi university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-19</approval_date>
        <contact_name>Ethics committee of Kharazmi Univercity.</contact_name>
        <contact_address>Shahid Keshvari complex, South Razan st, Mirdamad Endway. Physical education and Sport  Science Faculty, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
