<?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>IRCT20190426043377N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-05-22</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of  Water-based Stretching and Pilates Exercises on  Ankylosing Spondylitis</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Six Weeks of Water-based Stretching and Pilates Exercises on Pain, Function, Spine Posture, and Foot Pressure Distribution in Patients with Ankylosing Spondylitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56058</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple individual randomization using Random Number Allocation software was used. The assignment sequence is hidden by the numbered envelopes, which are numbered sequentially, and the envelopes are opened only after all the initial and basic assessments of the participants have been made. The random assignment sequence is performed by one of the study partners who is not involved in the evaluations and remains secret from the evaluators and other research colleagues, Blinding description: Outcome assessors do not know the assigned group of subjects; Because the assignment of individuals to groups is done by a person outside the research and after evaluating the pre-test, he introduces the assigned group to him.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ankylosing Spondylitis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Pilates in water: Pilates in water training program includes 12 sessions in the shallow, semi-deep and deep part of Azadi pool in Kermanshah on even days, 3 sessions per week with water temperature of 28 to 29 degrees Celsius. Each training session is 60 minutes and includes the following: The correct way of abdominal breathing and the basic principles of the sessions, including the main physical exercises in different positions (standing, floating in two positions, arch and back) and with resistance bands ( TheraBand Elastic Band Hygienic Corporation, Akron, OH, USA) Combines training balls, rims, clamps attached to bars around the pool, steppe and wood. Intervention 2: Control group: medication; NSAIDs &amp; Anti TNF (weekly, two weekly, and monthly). Intervention 3: Intervention group: Stretching exercise in water: The stretching program in water in this study includes 24 sessions of water exercise activity in the shallow part of Azadi pool in Kermanshah on even days, 3 sessions per week with water temperature of 33 to 30 degrees Celsius and intensity of exercise 50 Up to 75% of the maximum heart rate is performed. Each training session is 60 minutes, which is divided into 3 parts: 10 to 15 minutes of warm-up and 35-45 minutes of the main exercises. In general, the movements performed in this stage include a series of stretching movements, walking in directions. Jogging in water, upper limb movements while the lower limbs are immobile, lower limb movements while the upper limbs are fixed, and upper and lower limb movements will be performed simultaneously by the exercise instructor. The water is designed according to the condition and ability of patients according to the instructions of the American Physical Medicine Association.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farzaneh Gandomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi University, Bagh-e- Abrisham Ave.</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715663137</zip>
        <telephone>+98 83 3428 3272</telephone>
        <email>gandomi777@gmail.com</email>
        <affiliation>Razi Univesity</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Gandomi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Univesity, Bagh - e- Abrisham Ave.</address>
        <city>Kermanshsh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6715673136</zip>
        <telephone>+98 83 3428 3270</telephone>
        <email>gandomi777@gmail.com</email>
        <affiliation>Razi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No progression of the bamboo spine on radiographical scan
Bath Ankylosing Spondylitis Disease Activity Index (BAS-DAI) of 4.0 points or lower
Lack of regular exercise for the last 6 months
Use of medication for the last 6 months</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Those with uncontrolled chronic diseases or psychiatric history and currently on psychiatric medication</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ankylosing spondylitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Pilates in water: Pilates in water training program includes 12 sessions in the shallow, semi-deep and deep part of Azadi pool in Kermanshah on even days, 3 sessions per week with water temperature of 28 to 29 degrees Celsius. Each training session is 60 minutes and includes the following: The correct way of abdominal breathing and the basic principles of the sessions, including the main physical exercises in different positions (standing, floating in two positions, arch and back) and with resistance bands ( TheraBand Elastic Band Hygienic Corporation, Akron, OH, USA) Combines training balls, rims, clamps attached to bars around the pool, steppe and wood.</i_keyword>
      <i_keyword>Control group: medication; NSAIDs &amp; Anti TNF (weekly, two weekly, and monthly)</i_keyword>
      <i_keyword>Intervention group: Stretching exercise in water: The stretching program in water in this study includes 24 sessions of water exercise activity in the shallow part of Azadi pool in Kermanshah on even days, 3 sessions per week with water temperature of 33 to 30 degrees Celsius and intensity of exercise 50 Up to 75% of the maximum heart rate is performed. Each training session is 60 minutes, which is divided into 3 parts: 10 to 15 minutes of warm-up and 35-45 minutes of the main exercises. In general, the movements performed in this stage include a series of stretching movements, walking in directions. Jogging in water, upper limb movements while the lower limbs are immobile, lower limb movements while the upper limbs are fixed, and upper and lower limb movements will be performed simultaneously by the exercise instructor. The water is designed according to the condition and ability of patients according to the instructions of the American Physical Medicine Association.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome: pain. Timepoint: Before and after 8-week. Method of measurement: Pain by the visual analog scale (VAS).</prim_outcome>
      <prim_outcome>Spine range of motion (ROM). Timepoint: Before and after 8-week. Method of measurement: Spine range of motion by inclinometer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Spine posture. Timepoint: Before and after 8-week intervention. Method of measurement: Spine posture by Spinal mouse.</sec_outcome>
      <sec_outcome>Foot pressure distribution. Timepoint: Before and after 8-week intervention. Method of measurement: Foot pressure distribution by PT scan.</sec_outcome>
      <sec_outcome>Pulmonary Function. Timepoint: Before and after 8-week intervention. Method of measurement: Spirometry device.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-03</approval_date>
        <contact_name>Ethics Committee of Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Center No. 2, Shahid Beheshti Blvd. Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
