<?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>IRCT20210209050312N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-22</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Throwers Ten Exercises and Modified Stretching Movements on fatigue intensity  in patients with type 2 diabetes</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Throwers Ten Exercises and Modified Stretching Movements on fatigue intensity  in patients with type 2 diabetes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56169</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random block properties will be assigned using the List Randomization site and the creation of different number of blocks between the three groups of intervention 1 (Throwers Ten Exercises), intervention 2 (Modified Stretching Movements) and control.
Using the site (https://www.sealedenvelope.com/simple-randomiser/v1/lists) random blocks of different sizes and multiplied by 3 (9, 6, 3) will be created.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Type 2 diabetes.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Throwers Ten Exercises: Exercises in this group include 10 exercises in the upper limbs, including hands - elbows - shoulders - wrists and arms in different directions, which will be in accordance with the principle of overload (holding time and number of hands) that these exercises include ; Diagonal pattern in the form of hand opening, external rotation around the waist, external rotation at shoulder level, shoulder distance from shoulder surface, raising the scapula (scissors), Sidelying, lying on the abdomen in a horizontal position and limbs from Body rotation, pressing presses, UPS pressure, Bicep Curl, wrist extension or opening, wrist, lying down open, diagonal pattern with hand bending, internal rotation around waist, internal rotation on surface Shoulders, lying on the abdomen in a horizontal position and keeping the hands away from the body 100 degrees, Elbow Extension, diagonal pattern opening and bending the hands, diagonal pattern bending and opening the arms, internal and external rotation Around the waist, internal and external rotation at shoulder level, in the abdomen, opening and bending the elbow, bending the wrist, wrist open downwards (opposite to the previous position) and external rotation to the abdomen. These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning. Intervention 2: Intervention group 2: Modified Stretching Movements: These movements should be gentle and regular, including; Triceps, sliding against the wall, spine rotation, squatting, elbows close to the knees while moving, lifting while walking, twisting one leg, stretching the thighs while standing, stretching the muscles behind the thighs with the help of Sitting posture, Twin leg stretching, Diagonal stretching of the thigh in standing position, Stretching of the back thigh muscles with the help of standing posture, Horseshoe stretching in the standing position, Stretching of the thigh in the supine position, Cross stretching of the back thigh muscles with the help of cross, Stretching Standing twin and horseshoe muscles, bending the pelvis while kneeling, stretching the muscles behind the thighs while lying down with a towel, and stretching the twin and standing horseshoe muscles. These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning. Intervention 3: Control group: Non-intervention: This training group will not be given.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammadreza Abbasipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Side 12, Enghelab Street, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7581475581</zip>
        <telephone>+98 74 3331 3426</telephone>
        <email>bahmd626@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Abbasipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Side 12, Enghelab Street, Yasuj</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7581475581</zip>
        <telephone>+98 74 3331 3426</telephone>
        <email>bahmd626@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Ability to communicate and answer questions
Consent to participate in the study and sign the informed consent form
Age 30 to 60 years
At least 6 months have passed since the diagnosis of type 2 diabetes by an endocrinologist</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Perform amputations on the arms and legs
Neurological illnesses such as (depression and schizophrenia) and taking psychiatric medications
Previous participation in studies similar to current research
Cervical disc, lumbar disc and orthopedic problems
Class 3 and 4 heart failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E10-E11- E</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Diabetes mellitus</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 group1: Throwers Ten Exercises: Exercises in this group include 10 exercises in the upper limbs, including hands - elbows - shoulders - wrists and arms in different directions, which will be in accordance with the principle of overload (holding time and number of hands) that these exercises include ; Diagonal pattern in the form of hand opening, external rotation around the waist, external rotation at shoulder level, shoulder distance from shoulder surface, raising the scapula (scissors), Sidelying, lying on the abdomen in a horizontal position and limbs from Body rotation, pressing presses, UPS pressure, Bicep Curl, wrist extension or opening, wrist, lying down open, diagonal pattern with hand bending, internal rotation around waist, internal rotation on surface Shoulders, lying on the abdomen in a horizontal position and keeping the hands away from the body 100 degrees, Elbow Extension, diagonal pattern opening and bending the hands, diagonal pattern bending and opening the arms, internal and external rotation Around the waist, internal and external rotation at shoulder level, in the abdomen, opening and bending the elbow, bending the wrist, wrist open downwards (opposite to the previous position) and external rotation to the abdomen. These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning.</i_keyword>
      <i_keyword>Intervention group 2: Modified Stretching Movements: These movements should be gentle and regular, including; Triceps, sliding against the wall, spine rotation, squatting, elbows close to the knees while moving, lifting while walking, twisting one leg, stretching the thighs while standing, stretching the muscles behind the thighs with the help of Sitting posture, Twin leg stretching, Diagonal stretching of the thigh in standing position, Stretching of the back thigh muscles with the help of standing posture, Horseshoe stretching in the standing position, Stretching of the thigh in the supine position, Cross stretching of the back thigh muscles with the help of cross, Stretching Standing twin and horseshoe muscles, bending the pelvis while kneeling, stretching the muscles behind the thighs while lying down with a towel, and stretching the twin and standing horseshoe muscles. These exercises are 3 times a week for a month and each session is 30 to 45 minutes at 10 and 11 o'clock in the morning.</i_keyword>
      <i_keyword>Control group: Non-intervention: This training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Patients' fatigue at the beginning of the study (before the intervention) and immediately after the start of the study. Method of measurement: Smets's Multidimensional Fatigue Inventory.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-15</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj, Shahid Motahari Blvd., Yasuj University of Medical Sciences Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
