<?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>IRCT20090203001637N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-03-01</date_registration>
      <primary_sponsor>Research Deputy of Tarbiat Modares University</primary_sponsor>
      <public_title>Evaluation of the effects of exercise with flexible-bar on thoracic kyphosis angle  in young people (18 -35 years old)</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effects of 4 weeks exercise with flexible-bar on thoracic kyphosis angle and maximum voluntary contraction of thoracic muscles in postural hyperkyphosis people (18 -35 years old) with and without forward head posture</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53315</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Intervention group subjects will exercise with flexible bar and control group subjects will not have any exercise, Randomization description: Randomization method is performed by randomize table numbers, with due attention to sample size that is 24 people, are given one two digit code to each subject and researcher start by chance from one point of table to selection of subjects and do this work with closed eyes and put finger or pen nib on the table and select the numbers in the direction of row or column and do this work til the end of sample size and thus subjects stay on two intervention and control group by chance, Blinding description: Participant subjects are blinded to the kind of the group that they stay on it (intervention  and control). Thus subjects of two groups have no meet and assessments are done separately in even and odd days.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Subjects with  Postural hyper kyphosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: exercise with flexible-bar 6 days in 4 weeks (24 session) and 3 sets in each session. number (adding one set) and time (adding 5 seconds) of doing sets increase progressively each weak. to prevent from fatigue, allocated 30 seconds rest between each set. Intervention 2: Control group: No 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:
File of intervention program protocol and statistical analysis plan through publication of thesis and writingan article

When:
Starting 6 months after publication of results

To whom:
The research team of this study and other clinical academic researchers who are studying in favor of these patients

Conditions:
Researchers who intend to write a meta-analysis or systematic review articles are allowed to access document

Where to obtain:
Dr.sedighe kahrizi  , Zohreh vaseghi fard

How to obtain:
The request will be responded after getting the approval of university or the academic institution

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Vaseghi Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University, Jalale al e ahmad Ave, Kouye Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+9888284511</telephone>
        <email>v.zohreh@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedighe Kahrizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tarbiat Modares University,Jalale al e ahmad Ave, Kouye Nasr</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1411713116</zip>
        <telephone>+98 21 8828 4511</telephone>
        <email>Kahrizis@modares.ac.ir</email>
        <affiliation>Tarbiat Modares University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men and women  between18 to 35 years old
Having at least high school diploma education
Having pain less than 3 in  thoracic level with Numeric Pain Rating Scale(NRS)
Having hyperkyphosis angle more than 46  and less than  60 degree
Having cranio-vertebral angle less than  50 degree</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having body mass index more than 25
Having history of spinal surgery,infection,fracture,rheumatism
Pregnancy
History of professional exercise in upper trunk and shoulder
Scoliosis
Having respiration and heart problem
having Kyphosis with other  reasons for example structure deformity, metabolic tuberculosis, and  having large breast   in women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M40.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postural kyphosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: exercise with flexible-bar 6 days in 4 weeks (24 session) and 3 sets in each session. number (adding one set) and time (adding 5 seconds) of doing sets increase progressively each weak. to prevent from fatigue, allocated 30 seconds rest between each set</i_keyword>
      <i_keyword>Control group: No intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kyphosis angle. Timepoint: Before first exercise session and 24 hours post of last exercise session. Method of measurement: Flexicurve ruler.</prim_outcome>
      <prim_outcome>Craniovertebral(CVA) angle. Timepoint: Before first exercise session and 24 hours post of last exercise session. Method of measurement: Goniameter.</prim_outcome>
      <prim_outcome>Maximum Voluntary Contraction(MVC) of back extensor, lower trapezius, upper trapezius, neck extensor, levator scapulae muscles. Timepoint: Before  first exercise session and 24 hours post of last exercise session. Method of measurement: Recording with Electromyography system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of the  Quality of life questionnaire. Timepoint: Before first exercise session and 24 hours post of last exercise session. Method of measurement: Persian version of the Sf36 Questionnaire.</sec_outcome>
      <sec_outcome>Pain of the back region. Timepoint: Before first exercise session and 24 hours post of last exercise session. Method of measurement: Numeric Pain Rating Scale.</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>Research Deputy of Tarbiat Modares University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-15</approval_date>
        <contact_name>Ethics committee of ُTarbiat Modares University</contact_name>
        <contact_address>Tarbiat ModaresUuniversity, Nasr bridge, Jalal e al  e ahmad street, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
