<?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>IRCT20250507065634N13</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-01-01</date_registration>
      <primary_sponsor>The University of Guilan</primary_sponsor>
      <public_title>The effect of resistance and aerobic training on patients with multiple sclerosis.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of resistance and aerobic training on growth hormones cortisol, insulin-like growth factor 1, and depression in women with relapsing-remitting multiple sclerosis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-01-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87271</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After selecting the sample (40 eligible volunteers), all individuals are numbered. For randomization, opaque, light-tight, and sealed envelopes are used. Before the study begins, 40 envelopes are prepared, inside of which are placed equal numbers of papers labeled “Aerobic Exercise Test Group,” “Resistance Exercise Test Group,” and “Control Group.” The order of the papers in the envelopes is randomized, and the envelopes are then sealed. Upon entering the study, each individual randomly selects an envelope and is assigned to the experimental or control group based on its contents. This process ensures that the assignment of individuals to groups is completely random and that there is no possibility of prediction or interference in the assignment by the researcher or participants.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Control group: 10 participants who meet the inclusion criteria will be randomly assigned to the study as the control group. They will complete a depression questionnaire. ELISA will measure growth hormone, cortisol, and insulin-like growth factor levels before and after the intervention. However, they will not participate in any exercise. Intervention 2: First intervention group: 10 patients with multiple sclerosis referred to Besat Hospital in Rasht, who meet the inclusion criteria and are randomly assigned to participate in the study as the intervention group. They complete a depression questionnaire, and their growth hormone, cortisol, and insulin-like growth hormone levels are measured by ELISA and blood tests before starting the exercises. Then, they are placed in strength training sessions for 30-40 minutes for 24 sessions, 3 sessions per week, over 3 weeks. Before starting the sessions, 6 training sessions will be completed. The exercises are strength-based, and 5-10 minutes are dedicated to warming up (walking and stretching), 25-35 minutes to basic weight-bearing exercises, and 5 minutes to cool down (stretching). After completing the sessions, their growth hormone, cortisol, and insulin-like growth hormone levels are measured again by ELISA and blood tests after the exercises. Intervention 3: Second intervention group: The second intervention group consists of 10 women with relapsing–remitting multiple sclerosis who are referred to Ba’ath Hospital in Rasht and meet the inclusion criteria. Participants are randomly assigned to this group. At baseline, participants complete the Beck Depression Inventory (BDI), and serum levels of growth hormone, cortisol, and insulin-like growth factor 1 are measured before the initiation of the intervention through blood sampling using the Enzyme-Linked Immunosorbent Assay (ELISA) method. Subsequently, participants undergo an aerobic exercise training program for 8 weeks, with two sessions per week, totaling 16 sessions. Before the main intervention, 6 instructional sessions are conducted to familiarize participants with the correct performance of the exercises. Each aerobic exercise session lasts 20 to 40 minutes and consists of three parts to 10 minutes of warm-up (including walking and stretching exercises),20 to 30 minutes of the main exercise (walking), and 5 minutes of cool-down (stretching exercises). Exercise intensity is individually prescribed and monitored during the sessions based on the Borg Rating of Perceived Exertion (RPE) scale. After completion of the exercise program, serum levels of growth hormone, cortisol, and insulin-like growth factor 1 are re-measured through blood sampling using the ELISA method. Intervention 4: Intervention group: Third intervention group: 10 people with multiple sclerosis referred to Besat Hospital in Rasht, who meet the inclusion criteria and are randomly assigned to participate in the study as the intervention group. They complete a depression questionnaire and their growth hormone, cortisol, and insulin-like growth hormone levels are measured by ELISA and blood tests before starting the exercises. Then, they participate in combined aerobic and resistance training sessions at each person's home. The duration of the sessions is 28 sessions, 2 sessions per week. After completing the sessions, their growth hormone, cortisol, and insulin-like growth hormone levels are measured again by ELISA and blood tests after the exercises.</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:
Demographic data and the main outcome results of the research can be shared after de-identification and preserving the privacy of individuals.

When:
Data can be made available 4 months after the results are published and after personally identifiable information is removed.

To whom:
The study data and documentation will be available to researchers and scholars working at reputable academic and scientific institutions.

Conditions:
Research data and documentation may be used for scientific and research purposes. Users must undertake to keep non-identifiable data confidential.

Where to obtain:
If you need data, please contact

How to obtain:
After receiving and reviewing the request from the researcher, the request will be responded to as soon as possible.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Faeze Alipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahmadi Sabet, 10th Alley, Jomhouri Street, Lahijan, Gilan Province, Iran</address>
        <city>Lahijan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۴۱۹۸۸۵۱۳۶</zip>
        <telephone>+98 937 156 1655</telephone>
        <email>faezealipour2@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Payam Saidie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University Complex of Guilan, Km 5 Tehran Road, Khalij-e Fars Expressway, Rasht, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 911 194 3804</telephone>
        <email>payam.saidie@gmail.com</email>
        <affiliation>The University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range between 25 and 50 years
Women with depression in the Beck Depression Inventory range of 21-63 (BDI)
Having depressive disorder with a severity of 0–5 on the DPEI scale
Having regular menstrual cycles
Not using antidepressant medications
Disease severity (EDSS) between 0.5 and 5.5
No history of thyroid, renal, cardiovascular, or vascular diseases
Having at least a 2-month interval since the last exercise training
Non-smoker
No alcohol consumption
Having a relapsing-remitting type of Multiple Sclerosis (MS)</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Recurrence of the disease
Feeling of pain
Lack of necessary balance during the exercises
Participation in physiotherapy, massage therapy and rehabilitation programs in the last three months
History of cardiovascular diseases, epilepsy and migraines</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: 10 participants who meet the inclusion criteria will be randomly assigned to the study as the control group. They will complete a depression questionnaire. ELISA will measure growth hormone, cortisol, and insulin-like growth factor levels before and after the intervention. However, they will not participate in any exercise.</i_keyword>
      <i_keyword>First intervention group: 10 patients with multiple sclerosis referred to Besat Hospital in Rasht, who meet the inclusion criteria and are randomly assigned to participate in the study as the intervention group. They complete a depression questionnaire, and their growth hormone, cortisol, and insulin-like growth hormone levels are measured by ELISA and blood tests before starting the exercises. Then, they are placed in strength training sessions for 30-40 minutes for 24 sessions, 3 sessions per week, over 3 weeks. Before starting the sessions, 6 training sessions will be completed. The exercises are strength-based, and 5-10 minutes are dedicated to warming up (walking and stretching), 25-35 minutes to basic weight-bearing exercises, and 5 minutes to cool down (stretching). After completing the sessions, their growth hormone, cortisol, and insulin-like growth hormone levels are measured again by ELISA and blood tests after the exercises.</i_keyword>
      <i_keyword>Second intervention group: The second intervention group consists of 10 women with relapsing–remitting multiple sclerosis who are referred to Ba’ath Hospital in Rasht and meet the inclusion criteria. Participants are randomly assigned to this group. At baseline, participants complete the Beck Depression Inventory (BDI), and serum levels of growth hormone, cortisol, and insulin-like growth factor 1 are measured before the initiation of the intervention through blood sampling using the Enzyme-Linked Immunosorbent Assay (ELISA) method. Subsequently, participants undergo an aerobic exercise training program for 8 weeks, with two sessions per week, totaling 16 sessions. Before the main intervention, 6 instructional sessions are conducted to familiarize participants with the correct performance of the exercises. Each aerobic exercise session lasts 20 to 40 minutes and consists of three parts to 10 minutes of warm-up (including walking and stretching exercises),20 to 30 minutes of the main exercise (walking), and 5 minutes of cool-down (stretching exercises). Exercise intensity is individually prescribed and monitored during the sessions based on the Borg Rating of Perceived Exertion (RPE) scale. After completion of the exercise program, serum levels of growth hormone, cortisol, and insulin-like growth factor 1 are re-measured through blood sampling using the ELISA method.</i_keyword>
      <i_keyword>Intervention group: Third intervention group: 10 people with multiple sclerosis referred to Besat Hospital in Rasht, who meet the inclusion criteria and are randomly assigned to participate in the study as the intervention group. They complete a depression questionnaire and their growth hormone, cortisol, and insulin-like growth hormone levels are measured by ELISA and blood tests before starting the exercises. Then, they participate in combined aerobic and resistance training sessions at each person's home. The duration of the sessions is 28 sessions, 2 sessions per week. After completing the sessions, their growth hormone, cortisol, and insulin-like growth hormone levels are measured again by ELISA and blood tests after the exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before intervention and immediately after completion of the intervention. Method of measurement: Beck Depression Inventory (BDI).</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>The University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-20</approval_date>
        <contact_name>Research Ethics Committee of the Sports Sciences Research Institute</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
