<?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>IRCT20200501047256N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-20</date_registration>
      <primary_sponsor>Isfahan School of Sports Sciences</primary_sponsor>
      <public_title>Comparison of the effect of TRX and aerophytic exercises on MS patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of 8 weeks of selected TRX and aerophytic exercises on central stability function, balance and depth of sensation in patients with MS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/47679</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, using the randomization method, the block of individuals assigned to each group is almost equal and blocks are formed based on the considered variables.
How to build blocks: Subjects were divided into two equal groups by choosing their favorite sport based on their ability and interest.
In this research, the subjects were first given a written consent form to participate in the research.
Randomization tool: Random number table was used. And by the third person in different groups, including TRX training group (person 20) and Aerofitness training group (person 20), they were placed according to the entry and exit criteria of the research and received the intervention related to the same group.
There was no quasi-random and hidden method, Blinding description: According to your explanation, we did not have blindness in the subjects, and only to make our statistical analysis correct, without personal comment, statistical analysis was performed and blinding was done only in relation to statistical analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: TRX Group. In the intervention group, 1 exercise was performed using the TRX band for 8 weeks, 3 sessions per week, each session 1 hour for about 2 and a half months. Exercises started with stability and continued with more advanced exercises over time and during subsequent sessions. In both groups, the balance, strength and endurance of the central muscles of individuals were practiced, and finally these two intervention groups were compared with each other and the performance of individuals in both groups was examined. Intervention 2: Intervention Group 2: Aerofitness Group. In Intervention Group 2, the exercises were performed using Traband, dumbbells, sticks and balls for 8 weeks, 3 sessions per week, each session 1 hour for about 2 and a half months. The exercises started from beginner and stable and continued with advanced exercises. In both groups, the balance, strength and endurance of the central muscles of individuals were practiced and finally these two intervention groups were compared with each other and the performance of individuals in both groups was examined.</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 Due to the large amount of personal data and many tests that were performed in this area</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Marjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Gharani street</address>
        <city>Golpayegan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8771656574</zip>
        <telephone>+98 31 5745 3630</telephone>
        <email>f.marjani2913@gmail.com</email>
        <affiliation>University of Esfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Marjani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Qarni Street</address>
        <city>Golpayegan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8771656574</zip>
        <telephone>+98 31 5745 3630</telephone>
        <email>f.marjani2913@gmail.com</email>
        <affiliation>University of Esfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>A person with MS has been diagnosed by a neurologist
EDSS between 1 and 4
Feminine sex and not being pregnant
Age range between 20 and 50
The willingness to participate and complete the form of conscious consent to participate in the study</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Lack of exercise in other acute or chronic debilitating diseases
Non-prohibition of a specialist to perform exercises
Failure to complete pre-test research tests</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</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 1: TRX Group. In the intervention group, 1 exercise was performed using the TRX band for 8 weeks, 3 sessions per week, each session 1 hour for about 2 and a half months. Exercises started with stability and continued with more advanced exercises over time and during subsequent sessions. In both groups, the balance, strength and endurance of the central muscles of individuals were practiced, and finally these two intervention groups were compared with each other and the performance of individuals in both groups was examined.</i_keyword>
      <i_keyword>Intervention Group 2: Aerofitness Group. In Intervention Group 2, the exercises were performed using Traband, dumbbells, sticks and balls for 8 weeks, 3 sessions per week, each session 1 hour for about 2 and a half months. The exercises started from beginner and stable and continued with advanced exercises. In both groups, the balance, strength and endurance of the central muscles of individuals were practiced and finally these two intervention groups were compared with each other and the performance of individuals in both groups was examined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Measurement of central stability performance. Timepoint: Before training and 2 months after training. Method of measurement: Measurement of central stability function by lateral trunk tests, Sorenson and trunk flexors.</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>Isfahan School of Sports Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-04</approval_date>
        <contact_name>Ethics Committee of Isfahan University of Sports Sciences</contact_name>
        <contact_address>Hezar Jarib St., University of Isfahan, Central Library Esfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
