<?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>IRCT20251202068190N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-11</date_registration>
      <primary_sponsor>University of Guilan</primary_sponsor>
      <public_title>The effect of resistance exercise with and without blood flow restriction during different phases of the menstrual cycle in trained women</public_title>
      <acronym></acronym>
      <scientific_title>Hormonal, Lactate, and Cardiac Autonomic Responses to Resistance Exercise with and Without Blood Flow Restriction at Menstrual Cycle Phases in Trained Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-17</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88341</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Menstrual cycle status.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Resistance exercise without Blood Flow Restriction; Participants will perform traditional resistance exercise at an intensity of 70% of one-repetition maximum (1RM). The training protocol will include of two exercises, leg press and leg extension, each will be performed for 4 sets of 10 repetitions. Rest intervals will consist of 1 minute between sets and 2-3 minutes between two exercises. The intervention will be conducted over two consecutive menstrual cycles, such that one session will be performed during the follicular phase and one session during the luteal phase. Intervention 2: Intervention group: Resistance exercise with Blood Flow Restriction (BFR); Participants in this group will perform resistance exercises (leg press and leg extension) at an intensity of 30% of 1RM. BFR will be applied using a cuff placed at the proximal portion of the lower limb, with a pressure set at 60% of Limb Occlusion Pressure (LOP). The training protocol will consist of 4 sets (30-15-15-15 repetition), with one minute of rest between sets and 2-3 minutes between two exercises. The intervention will be conducted over two consecutive menstrual cycles, such that one session will be performed during the follicular phase and one session during the luteal phase.</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:
This document includes a complete description of the study design, training protocol, intervention schedule, measurement methods for all variables, and study procedures, prepared to enhance transparency and reproducibility of the results.

When:
After publication of the study results

To whom:
Researchers and  the academic staff

Conditions:
The data are available solely for research purposes, subject to confidentiality requirements and approval by the principal investigator.

Where to obtain:
Through the principal investigator.

How to obtain:
Email of the principal investigator

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zahra Aftabi Talami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Guilan, 5th Kilometer of  Rasht-Qazvin road, Rasht, Guilan province, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3369 0685</telephone>
        <email>zahraaftabi.t@gmail.com</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Mehrabani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Guilan, 5th Kilometer of  Rasht-Qazvin road, Rasht, Guilan province, Iran</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4199613776</zip>
        <telephone>+98 13 3369 0685</telephone>
        <email>Mehrabanij@guilan.ac.ir</email>
        <affiliation>University of Guilan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Trained women with at least six months of regular resistance training experience
Regular menstrual cycles (28–32 days)
Range of age between 20 to 30 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Taking hormonal medications or oral contraceptives during the past six months
Consumption of nutritional supplements or caffeine at least 48 hours prior to testing
The history of cardiovascular, metabolic, endocrine, or neurological diseases</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Resistance exercise without Blood Flow Restriction; Participants will perform traditional resistance exercise at an intensity of 70% of one-repetition maximum (1RM). The training protocol will include of two exercises, leg press and leg extension, each will be performed for 4 sets of 10 repetitions. Rest intervals will consist of 1 minute between sets and 2-3 minutes between two exercises. The intervention will be conducted over two consecutive menstrual cycles, such that one session will be performed during the follicular phase and one session during the luteal phase.</i_keyword>
      <i_keyword>Intervention group: Resistance exercise with Blood Flow Restriction (BFR); Participants in this group will perform resistance exercises (leg press and leg extension) at an intensity of 30% of 1RM. BFR will be applied using a cuff placed at the proximal portion of the lower limb, with a pressure set at 60% of Limb Occlusion Pressure (LOP). The training protocol will consist of 4 sets (30-15-15-15 repetition), with one minute of rest between sets and 2-3 minutes between two exercises. The intervention will be conducted over two consecutive menstrual cycles, such that one session will be performed during the follicular phase and one session during the luteal phase.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Growth hormone. Timepoint: Pre-test (before the exercise session) and post-test (after the test/end of the exercise session). Method of measurement: Serum growth hormone concentration will be measured through blood sampling and laboratory assessment using the Enzyme-Linked Immunosorbent Assay (ELISA) method.</prim_outcome>
      <prim_outcome>Cortisol. Timepoint: Pre-test (before the exercise session) and post-test (after the test/end of the exercise session). Method of measurement: Serum cortisol concentration will be measured using blood sampling and laboratory analysis by the enzyme-linked immunosorbent assay (Enzyme-Linked Immunosorbent Assay).</prim_outcome>
      <prim_outcome>Blood Lactate. Timepoint: Pre-test (before the exercise session) and post-test (after the test/end of the exercise session). Method of measurement: Plasma lactate level will be measured using blood sampling and laboratory analysis by a standard enzymatic method.</prim_outcome>
      <prim_outcome>Heart Rate Variability. Timepoint: Heart rate variability will be recorded and analyzed in 5-minute time windows during the pre-test period and immediately after the test. Method of measurement: Heart rate variability will be measured and analyzed using a Polar H10 heart rate sensor.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood Pressure. Timepoint: Pre-test (before the exercise session) and post-test up to 60 minutes after the test. Method of measurement: By using Sphygmomanometer.</sec_outcome>
      <sec_outcome>Rating of Perceived Exertion (RPE). Timepoint: Immediately after completion of each set of the exercise. Method of measurement: By using the Borg rating of perceived exertion scale.</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>University of Guilan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-14</approval_date>
        <contact_name>Ethics committee of University of Guilan</contact_name>
        <contact_address>University of Guilan, 5th Kilometer of  Rasht-Qazvin road, Rasht, Guilan province, Iran Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
