<?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>IRCT20210217050393N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-26</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluating the effect of beetroot extract supplementation coinciding with resistance training  in rehabilitation of athletes with anterior cruciate ligament rupture</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effect of beetroot extract supplementation coinciding with resistance training on maximum concentric peak torque and power of the quadriceps and hamstring muscles in semi-professional male athletes after anterior cruciate ligament surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56772</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: This study is a non-randomized parallel clinical trial with control group.</study_design>
      <phase>2</phase>
      <hc_freetext>Anterior cruciate ligament rehabilitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 250 cc beetroot extract containing 40% ADI nitrate based on body weight will be given to the athlete two hours before exercise in two non-consecutive sessions. The duration of the intervention will be 4 weeks, which includes 12 sessions of resistance training and 8 servings of beetroot supplement. Sachets containing extract powder will be prepared by the Mashhad School of Pharmacy. Intervention 2: Control group: Resistance training for 4 weeks including 12 resistance training sessions.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Rezvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code:  9177948564</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99191-91778</zip>
        <telephone>+98 51 3800 2418</telephone>
        <email>rezvanir@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Rezvani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Medicine, Mashhad University of Medical Sciences. Azadi Square, Campus of University, Mashhad, Iran Postal Code:  9177948564</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>99191-91778</zip>
        <telephone>+98 51 3800 2418</telephone>
        <email>rezvanir@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male semi-professional athletes who play in provincial teams in the fields of football, futsal, volleyball and basketball
Undergoing ACL reconstructing surgery using allograft technique
90 days have passed since the ACL reconstruction surgery
Adhere to the same protocol, which includes 40 sessions of physiotherapy with 60 sessions of exercise therapy, from the day of surgery to the end of 90 days for all subjects
Willingness to participate in research
Age between 18 and 35 years old</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Disease including: diabetes, kidney stones, gallstones, cancer and other serious diseases
Taking any medication or performing extra exercise compared to the research protocol
Using oral and injectable nutritional supplements before and after the research period
Consumption of any herbal medicine
Allergy to beetroot
Smoking
Alcohol consumption
History of performing any surgery on the operated limb
Bilateral knee injuries
Damage to other tissues and ligaments of the knee, including intra-articular fractures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.50</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Muscle wasting and atrophy, not elsewhere classified, unspecified site</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: 250 cc beetroot extract containing 40% ADI nitrate based on body weight will be given to the athlete two hours before exercise in two non-consecutive sessions. The duration of the intervention will be 4 weeks, which includes 12 sessions of resistance training and 8 servings of beetroot supplement. Sachets containing extract powder will be prepared by the Mashhad School of Pharmacy</i_keyword>
      <i_keyword>Control group: Resistance training for 4 weeks including 12 resistance training sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Maximum concentric torque of quadriceps and hamstring at 60 degree per second. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Isokinetic device at 60 degree per second.</prim_outcome>
      <prim_outcome>Maximum concentric torque of quadriceps and hamstring at 90 degree per second. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Isokinetic device at 90 degree per second.</prim_outcome>
      <prim_outcome>Maximum concentric torque of quadriceps and hamstring at120 degree per second. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Isokinetic device at 120 degree per second.</prim_outcome>
      <prim_outcome>Power of quadriceps and hamstring muscles at 60 degree per second. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Isokinetic device at 60 degree per second.</prim_outcome>
      <prim_outcome>Power of quadriceps and hamstring muscles at 90 degree per second. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Isokinetic device at 90 degree per second.</prim_outcome>
      <prim_outcome>Power of quadriceps and hamstring muscles at 120 degree per second. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Isokinetic device at 120 degree per second.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Body composition. Timepoint: Baseline and 48 hours after the last exercise session (4 weeks). Method of measurement: Body analyzer device.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-04-20</approval_date>
        <contact_name>Ethics committee of Mashhad university of medical sciences</contact_name>
        <contact_address>Mashhad university of medical sciences, Azadi squre Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
