<?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>IRCT20120912010824N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-07</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Resistance Training and Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Effects of 12 weeks of Resistance Exercise Training on Serum Indices in Permeability of Blood Brain Barrier Controlling, oxidative stress, Functional capacity and cognitive performance in Women with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-05-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71215</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: 30 eligible women with relapsing-remitting MS were selected to enter the study based on inclusion/exclusion criteria. Finally, the participants were divided into two groups a) without resistance training (15 people) and b) resistance training (15 people) by simple random method and using a table of random numbers. In addition, fifteen healthy, non-athlete women aged 18-45 were selected as a healthy control group (n = 15) to monitor the current research data.</study_design>
      <phase>3</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Resistance Training, Based on the recommendations  in Resistance training (RT) for pwMS, the RT program included 12 weeks, 3 sessions/week, 60-80% 1RM for 60–90 min/session. The RT program consisted of three exercises for the lower extremity (leg press, lunges, and deadlift), three exercises for the upper extremity (bench press, wide grip lat pulldown and front dumbbell raise).The training program started with a 5-minute warm-up on the ergometer bike, followed by the main exercises, and then the training program ended in each session with a 5-minute cool-down program on the ergometer bike and 5 minutes of stretching and relaxation.  Also, during this period, Patients received their drug treatment supervised by specialist neurologist. Intervention 2: Control group: Women with MS without resistance training, These women did not participate in any exercise training during the 12 weeks of intervention and performed their normal daily activities. Also, during this period, they received their drug treatment supervised by specialist neurologist. Intervention 3: Control group2:  Healthy women without resistance training, in the same age group (18-45) were selected as a healthy control group to monitor the research data.These women did not participate in any exercise training during the 12 weeks of intervention and performed their normal daily activities.</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:
No known time

When:
No known time

To whom:
Scientific

Conditions:
Research using

Where to obtain:
نویسنده مسول

How to obtain:
Email

Comments:
No</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasrin Niazi Nezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi University</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414874</zip>
        <telephone>0834283276</telephone>
        <email>n.niazi64@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdolhossein Parnow</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi university</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6714414874</zip>
        <telephone>+98 83 3428 3276</telephone>
        <email>parnowabdolhossein@gmail.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>history of at least two-year diagnosed RR-MS
EDSS ≤4
no other chronic diseases (metabolic, cardiovascular, renal, …)
no history of regular physical activity in the previous 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No contracting COVID-19</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified mental disorders due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Resistance Training, Based on the recommendations  in Resistance training (RT) for pwMS, the RT program included 12 weeks, 3 sessions/week, 60-80% 1RM for 60–90 min/session. The RT program consisted of three exercises for the lower extremity (leg press, lunges, and deadlift), three exercises for the upper extremity (bench press, wide grip lat pulldown and front dumbbell raise).The training program started with a 5-minute warm-up on the ergometer bike, followed by the main exercises, and then the training program ended in each session with a 5-minute cool-down program on the ergometer bike and 5 minutes of stretching and relaxation.  Also, during this period, Patients received their drug treatment supervised by specialist neurologist.</i_keyword>
      <i_keyword>Control group: Women with MS without resistance training, These women did not participate in any exercise training during the 12 weeks of intervention and performed their normal daily activities. Also, during this period, they received their drug treatment supervised by specialist neurologist.</i_keyword>
      <i_keyword>Control group2:  Healthy women without resistance training, in the same age group (18-45) were selected as a healthy control group to monitor the research data.These women did not participate in any exercise training during the 12 weeks of intervention and performed their normal daily activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Indices Related to Blood Brain Barrier Permeability (matrix metalloproteinases (MMPs) and specific tissue inhibitors of MMPs, s100B). Timepoint: pre and post of exercise protocol. Method of measurement: blood sampling.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Cognitive Performance. Timepoint: pre and post of exercise protocol. Method of measurement: The Brief International Cognitive Assessment for MS (BICAMS)  was used to examine information processing speed and immediate verbal and visual recall. The BICAMS consists of the Symbol Digit Modalities Test (SDMT), California Verbal Learning Test-II (CVLT-II) and the Brief Visuospatial Memory Test- Revised (BVMT-R).</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>Personal</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-24</approval_date>
        <contact_name>Research Working Group at the Sports Sciences Research Institute</contact_name>
        <contact_address>Motahari Street Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
