<?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>IRCT20190831044649N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-20</date_registration>
      <primary_sponsor>Payame Noor University</primary_sponsor>
      <public_title>The effect of two types of training with and without blood flow restriction on some cytokines in men</public_title>
      <acronym></acronym>
      <scientific_title>The effect of two types of resistance training with and without blood flow restriction on some pro-inflammatory cytokines in overweight men</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84192</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Eligible participants (n=50), who were screened based on the inclusion and exclusion criteria, were randomly assigned to one of the five study groups. To ensure genuine random allocation, a standard randomization procedure, such as using a random number table, was employed. This process was conducted in a manner that prevented the researchers from predicting which group a subsequent participant would be assigned to, thereby minimizing selection bias.
To guarantee an equal number of participants across all groups (10 per group), a blocked randomization method was utilized. In this technique, a fixed block size (e.g., 5 or 10) was defined, and the sequence of assignments within each block was generated randomly. This approach ensures that at the end of the recruitment period, the number of participants in all groups is precisely balanced, Blinding description: Due to the nature of the intervention (resistance exercise training), implementation of double blinding was not feasible in this study. Participants were explicitly aware of their assigned group (resistance training with or without blood flow restriction), and trainers as well as researchers were necessarily informed about the type of intervention being administered.

However, to enhance methodological rigor and minimize potential bias:

Independent assessors , responsible for measuring outcome variables such as BMI and other anthropometric indices, were blinded to participants’ group allocations (single blinding ).
Statistical analyses were conducted by data analysts who remained unaware of the group assignments throughout the analytical process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>overweight.</hc_freetext>
      <i_freetext>Intervention 1: Group 1: Resistance Training with Elastic BandsParticipants in this group performed a resistance training program using TheraBand elastic bands for 6 weeks, with 3 sessions per week (total of 18 sessions). Each session consisted of 10 minutes of warm-up, 25–35 minutes of main exercise, and 5 minutes of cool-down. The training protocol began with 2 sets of 8 repetitions at ∼60% of 1RM and progressively increased to 3 sets of 10 repetitions at ∼75% of 1RM by the sixth week. The exercises included 6 movements (3 upper-body and 3 lower-body). Active rest periods of 60 seconds were implemented between sets. Intervention 2: Group 2: Resistance Training with DumbbellsThis group performed a resistance training program using adjustable dumbbells for 6 weeks, with 3 sessions per week. The session structure was identical to that of Group 1. The protocol included 12 exercises (6 upper-body and 6 lower-body) performed on alternating days. Training intensity started at 2 sets of 8 repetitions at 60% of 1RM and progressed to 3 sets of 10 repetitions at 75% of 1RM by the sixth week. Active rest intervals of 60 seconds were maintained between sets. Intervention 3: Group 3: Resistance Training with Elastic Bands + Blood Flow Restriction (BFR)The training protocol for this group was identical to that of Group 1 but was combined with blood flow restriction (BFR). Specialized rubber tourniquets (width: 3–5 cm) were applied to the proximal portion of the limbs. The tourniquet pressure was calibrated using Doppler ultrasonography to ensure complete arterial occlusion. The tourniquets remained inflated throughout the entire session (including rest intervals) and were deflated only after the session concluded. The procedure was supervised by a medical professional to ensure safety. Intervention 4: Group 4: Resistance Training with Dumbbells + Blood Flow Restriction (BFR)The training protocol for this group was identical to that of Group 2 but was combined with blood flow restriction (BFR). The BFR application protocol (tourniquet type, pressure, and supervision) was identical to that used in Group 3. Participants performed dumbbell exercises at the same volume and intensity as Group 2, with simultaneous application of BFR.</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:
Information about the main outcome

When:
6 months after results are published

To whom:
حققین شاغل در موسسات دانشگاهی و علمی

Conditions:
مقایسه با تحقیقات محققین دیگر

Where to obtain:
آدرس پست الکترونیک

How to obtain:
پاسخ به درخواست حداکثر یک هفته پس از ایمیل  تقاضاکننده قابل وصول است

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Barzegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bābol Keshvari Square - Imam Reza (AS) Street، Khodadad 17 Alley</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4716654849</zip>
        <telephone>+98 11 3225 7793</telephone>
        <email>ali_barzegari@pnu.ac.ir</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Barzegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bābol Keshvari Square - Imam Reza (AS) Street، Khodadad Alley 17</address>
        <city>Babol</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4716654849</zip>
        <telephone>009811322257793</telephone>
        <email>ali_barzegari@pnu.ac.ir</email>
        <affiliation>Payame Noor University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The subjects' age should be between 20 and 30 years old.
Subjects are overweight.
Subjects should not have a history of any specific illness.
Not using drugs and tobacco</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Age outside the defined range of 20 to 30 years.
Body Mass Index (BMI) outside the defined overweight range or severe obesity (BMI ≥ 35 kg/m²).
History of uncontrolled cardiovascular, respiratory, renal, hepatic, or metabolic diseases
Use of medications known to significantly affect metabolism, inflammation, or immune function
Regular structured physical activity or exercise training within the past 3 months.
Tobacco smoking or alcohol consumption within the past 6 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E66.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obesity, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Group 1: Resistance Training with Elastic BandsParticipants in this group performed a resistance training program using TheraBand elastic bands for 6 weeks, with 3 sessions per week (total of 18 sessions). Each session consisted of 10 minutes of warm-up, 25–35 minutes of main exercise, and 5 minutes of cool-down. The training protocol began with 2 sets of 8 repetitions at ∼60% of 1RM and progressively increased to 3 sets of 10 repetitions at ∼75% of 1RM by the sixth week. The exercises included 6 movements (3 upper-body and 3 lower-body). Active rest periods of 60 seconds were implemented between sets.</i_keyword>
      <i_keyword>Group 2: Resistance Training with DumbbellsThis group performed a resistance training program using adjustable dumbbells for 6 weeks, with 3 sessions per week. The session structure was identical to that of Group 1. The protocol included 12 exercises (6 upper-body and 6 lower-body) performed on alternating days. Training intensity started at 2 sets of 8 repetitions at 60% of 1RM and progressed to 3 sets of 10 repetitions at 75% of 1RM by the sixth week. Active rest intervals of 60 seconds were maintained between sets.</i_keyword>
      <i_keyword>Group 3: Resistance Training with Elastic Bands + Blood Flow Restriction (BFR)The training protocol for this group was identical to that of Group 1 but was combined with blood flow restriction (BFR). Specialized rubber tourniquets (width: 3–5 cm) were applied to the proximal portion of the limbs. The tourniquet pressure was calibrated using Doppler ultrasonography to ensure complete arterial occlusion. The tourniquets remained inflated throughout the entire session (including rest intervals) and were deflated only after the session concluded. The procedure was supervised by a medical professional to ensure safety.</i_keyword>
      <i_keyword>Group 4: Resistance Training with Dumbbells + Blood Flow Restriction (BFR)The training protocol for this group was identical to that of Group 2 but was combined with blood flow restriction (BFR). The BFR application protocol (tourniquet type, pressure, and supervision) was identical to that used in Group 3. Participants performed dumbbell exercises at the same volume and intensity as Group 2, with simultaneous application of BFR.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>TNF-a. Timepoint: two stages: pre-test and post-test. Method of measurement: Sandwich ELISA kit.</prim_outcome>
      <prim_outcome>IL-1b. Timepoint: two stages: pre-test and post-test. Method of measurement: Sandwich ELISA kit.</prim_outcome>
      <prim_outcome>IL-6. Timepoint: two stages: pre-test and post-test. Method of measurement: Sandwich ELISA kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Descriptive Indice: Height. Timepoint: pre-test. Method of measurement: Height was measured using a wall-mounted stadiometer (Model: Seca 213, Germany) with a measurement unit of centimeters (cm) and an instrument precision of 0.1 cm.</sec_outcome>
      <sec_outcome>Weight. Timepoint: In two stages: pre-test and post-test. Method of measurement: Body weight was measured using a calibrated digital scale (Model: Seca 813, Germany) with a precision of 0.1 kg.</sec_outcome>
      <sec_outcome>Body Mass Index (BMI). Timepoint: In two stages: pre-test and post-test. Method of measurement: Body Mass Index (BMI) is a derived anthropometric measure calculated from direct measurements of body weight and height.</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>Payame Noor University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-19</approval_date>
        <contact_name>Research Ethics Committee of Payam Noor University</contact_name>
        <contact_address>Tehran, Mini City, Artesh Blvd., 1st Oil City, Nakhl St., Central Organization of Payam Noor University Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
