<?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>IRCT20220526054997N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-31</date_registration>
      <primary_sponsor>Shahid Bahonar Univercity of Kerman</primary_sponsor>
      <public_title>The effects of eight weeks swing exercises on functional ability and quality of life in multiple sclerosis women with emphasis on Expanded disability Status Scale</public_title>
      <acronym></acronym>
      <scientific_title>The effects of swing training on functional ability and quality of life in multiple sclerosis women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-01-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>57</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65899</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: A stratified randomization method was used, first, 80 eligible patients in the disability range of 2 to 6.5 were selected to participate in the protocol in cooperation with the MS Association. Then the people were numbered and in order to hide the random allocation, all the numbers were placed inside a sealed envelope. after mixing the numbers, the numbers were randomly selected and classified into three groups. The basis is that if the patient did not meet the conditions of the group with mild disability, he would be put back into the envelope, Blinding description: One-way blind:
The participants did not know about the grouping of the research, according to which category of disability was classified. In addition, they did not know about the possible effects of the protocol and exercise on the functional factors of the upper and lower limbs and mental performance, but the patients were told that the exercises are effective on your physical factors, but in order not to mislead that this The pre-test measures the performance of the upper limbs and exercises are provided to check these changes. No information was given so as not to affect the tests.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: They performed suspended and semi-suspended swing exercises for eight weeks. Training protocol: First, ten minutes of warm-up, which included stretching and kinetic movements with a medium and low level, were performed, and then the swing exercises began. The protocol consists of eight weeks of suspended and unstable exercises, which were performed using a swing tool, and the intensity of the exercise was changed by increasing the repetitions and changing the grips and leveling of the movements. Intervention 2: The second intervention group: They performed suspended and semi-suspended swing exercises for eight weeks. Training protocol: First, ten minutes of warm-up, which included stretching and kinetic movements with a medium and low level, were performed, and then the swing exercises began. The protocol consists of eight weeks of suspended and unstable exercises, which were performed using a swing tool, and the intensity of the exercise was changed by increasing the repetitions and changing the grips and leveling of the movements. Intervention 3: Control group: The patients in this group did their normal daily activities and the things that the relevant doctor had announced and no restrictions were imposed by the researcher.</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:
All statistical information, statistical results,EDSS, quality of life results are accessible

When:
Access starts one month after the results are published

To whom:
Researchers and Health centers

Conditions:
In order to use the results to raise and improve the conditions of multiple sclerosis patients

Where to obtain:
sara sepehrifar
sepehri.sara73@gmail.com

How to obtain:
after a week they will receive it

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sara Sepehri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahab Street,. 7th Alley, Left Side , 6thBulding</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616884987</zip>
        <telephone>+98 939 489 8646</telephone>
        <email>sepehri.sara73@gmail.com</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mansour Sahebozamani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar University of Kerman- Faculty of Physical Education and Sport Sciences- Department of Sport Pathology and Corrective Exercises</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7616884987</zip>
        <telephone>+98 913 397 0521</telephone>
        <email>sahebozamani@yahoo.com</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>at least a year should passed from patients diagnosis of MS
no other acute or chronic infection in body like mental, cardiovascular, respiratory, skin disease, high or low blood pressure, high or low eye pressure
ability to attend meetings regularly
not having a regular sports history
having disability in a specific range  4≥EDSS≥2 , 6.5≥EDSS≥4.5
absence of pregnancy
at least patients must be 30 years old</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>46 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Inability to walk or need assistance in walking
MS relapse at least two months before the intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: They performed suspended and semi-suspended swing exercises for eight weeks. Training protocol: First, ten minutes of warm-up, which included stretching and kinetic movements with a medium and low level, were performed, and then the swing exercises began. The protocol consists of eight weeks of suspended and unstable exercises, which were performed using a swing tool, and the intensity of the exercise was changed by increasing the repetitions and changing the grips and leveling of the movements.</i_keyword>
      <i_keyword>The second intervention group: They performed suspended and semi-suspended swing exercises for eight weeks. Training protocol: First, ten minutes of warm-up, which included stretching and kinetic movements with a medium and low level, were performed, and then the swing exercises began. The protocol consists of eight weeks of suspended and unstable exercises, which were performed using a swing tool, and the intensity of the exercise was changed by increasing the repetitions and changing the grips and leveling of the movements.</i_keyword>
      <i_keyword>Control group: The patients in this group did their normal daily activities and the things that the relevant doctor had announced and no restrictions were imposed by the researcher.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Functional Ability of Upper Limb. Timepoint: Pre Test- 4th week of intervention - 6th week of intervention and post test. Method of measurement: 9hole peg test.</prim_outcome>
      <prim_outcome>Fuctional ability of lower extremity. Timepoint: pre-test, fourth week, sixth week and eighth week(post-test). Method of measurement: 25foot walk test.</prim_outcome>
      <prim_outcome>Processing speed of memory. Timepoint: pre-test, fourth week, sixth week and eighth week(post-test). Method of measurement: paced audiotory serial addition test.</prim_outcome>
      <prim_outcome>The effect of swing exercises on the quality of life of women patients with multiple sclerosis. Timepoint: Pre-test and post-test. Method of measurement: short form 36 question.</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>Sara sepehri</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-30</approval_date>
        <contact_name>National Ethics committee of Shahid Bahonar University of Medical Sciences</contact_name>
        <contact_address>pazhohesh Blvd., shahid bahonar univercity kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
