<?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>IRCT20200131046322N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-26</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of educating stretching exercise on impact and Quality of Life in Patients on drug therapy with Fibromyalgia</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of educating stretching exercise on impact and Quality of Life in Patients on drug therapy with Fibromyalgia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52895</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients according to the inclusion criteria are assigned to the following blocks, respectively (assuming the presence of 14 new patients per month): so that the first and second person according to the blocks are part of the intervention group and the third and fourth person are control group and similarly random Making is done. The last block is less and the cause of randomization is the homogenization of the two groups in terms of number.
0001: Case 0005: Placebo 0009: Case 0013: Placebo
0002: Case 0006: Placebo 0010: Case 0014: Placebo
0003: Placebo 0007: Case 0011: Case
0004: Placebo 0008: Case 0012: Placebo
__________________________________________
0015: Case 0019: Placebo 0023: Case 0027: Placebo
0016: Case 0020: Case 0024: Placebo 0028: Placebo
0017: Case 0021: Placebo 0025: Placebo
0018: Case 0022: Placebo 0026: Case
__________________________________________
0029: Placebo 0032: Placebo 0035: Case 0038: Case
0030: Case 0033: Placebo 0036: Case 0039: Placebo
0031: Case 0034: Placebo 0037: Placebo 0040: Case
0041: Case 0042: Placebo
__________________________________________
0043: Case 0045: Case 0047: Placebo 0049: Case
0044: Placebo 0046: Case 0048: Placebo 0050: Placebo.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fibromyalgia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: exercise therapy. 5-week period, static stretching exercises including neck flexor &amp; extensor stretch, wrist extensor stretching, hip abductor stretch, gluteus maximus stretch, hip adductor stretch and piriformis stretching (taken from the book Rehabilitation techniques for sports medicine and athletic training-6th edition.William E Prentice). Each movement 2 days a week and repeated 3 times, the first week 10 seconds and a 5 second increase in subsequent weeks (fifth week 30 seconds) and to the extent of feeling unwell. Intervention 2: Control group: Pharmacotherapy.</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 We have not decided yet</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Madani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 6 , Mostafavian Clinic , 3th Ave , Razi St</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816868890</zip>
        <telephone>+98 11 3336 6552</telephone>
        <email>z.madani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Madani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 6 , Mostafavian Clinic , 3th Ave , Razi St</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816868890</zip>
        <telephone>+98 11 3336 6552</telephone>
        <email>z.madani@mazums.ac.ir</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with fibromyalgia diagnosed by a rheumatologist, referred to a psychiatric clinic and treated with sertraline or fluoxetine or duloxetine
Female gender
Age over 18 years
Have consent to participate in the study.
Be literate
Lack of suicidal thoughts
Do not take corticosteroids
No secondary fibromyalgia
Not participating in another clinical trial in the last six months
Do not have heart disease, uncontrolled blood pressure and diabetes and other rheumatic diseases
Not to have any neurological, metabolic or orthopedic problems prevents all sports-related sports
Not abusing drugs, cigarettes and other substances according to the statement of the person or companion
Not pregnant or breastfeeding
A maximum of 3 months have passed since the start of drug treatment and drug treatment remains constant during the plan</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M79.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fibromyalgia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: exercise therapy. 5-week period, static stretching exercises including neck flexor &amp; extensor stretch, wrist extensor stretching, hip abductor stretch, gluteus maximus stretch, hip adductor stretch and piriformis stretching (taken from the book Rehabilitation techniques for sports medicine and athletic training-6th edition.William E Prentice). Each movement 2 days a week and repeated 3 times, the first week 10 seconds and a 5 second increase in subsequent weeks (fifth week 30 seconds) and to the extent of feeling unwell</i_keyword>
      <i_keyword>Control group: Pharmacotherapy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of Life. Timepoint: 0,5,10 weeks. Method of measurement: SF-36 questionnaire.</prim_outcome>
      <prim_outcome>Effect of fibromyalgia. Timepoint: 0,5,10 weeks. Method of measurement: Fibromyalgia Impact Questionnaire (FIQ).</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>Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-02</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Fanavarihaye Novin University, next to Bagheban clinic, Shahid beheshti boulevard Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
