<?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>IRCT20170927036459N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-09-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effects of high-intensity interval training and L-Citrulline supplementation on neuromuscular indices in elders</public_title>
      <acronym></acronym>
      <scientific_title>Effects of high-Intensity interval training combined with L-Citrulline supplementation on neuromuscular indices in elderly men with Sarcopenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65333</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: At first, the subjects will be selected using a simple random method. Then, using a table of random numbers, they are divided into four groups. Therefore, each candidate will be assigned a two-digit number. Equal to the sample size, the same number of digits is determined for the selection of individuals (five-digit numbers whose last two digits are similar to the existing codes) that are randomly assigned to one of the groups It will be given. This will continue until the number of people in each group is completed. Therefore, the researcher will not have the option to change the status of the assignment or predict it. Random hiding will be done by a third party who does not participate in other stages of the intervention, Blinding description: The participants will be randomly allocated in to 4 groups and  will not aware of the type of treatment. For this purpose, we informed each subject in the form of a confidential letter about all the tasks and their grouping requirements. We reported the status of the subject grouping through the code selected for each group and no group names were recorded in the subjects' letters.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sarcopenia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Exercise+Placebo: high intensity interval training performed for 8 weeks and 3 sessions per week that included 30 seconds cycling exercise on ergometer (intensity of 85-90% HR reserve). In addition, This group received one capsule  similar (placebo) to supplement L-citrulline for 8 weeks. Intervention 2: Intervention group: Supplement group: L-citrulline supplement consumed in single 6 g-dose daily for 8 weeks. Intervention 3: Intervention group: Exercise+supplement group: participants of this group performed high intensity interval training performed for 8 weeks and 3 sessions per week that included 30 seconds cycling exercise on ergometer (intensity of 85-90% HR reserve). In addition, this group received L-citrulline supplement in single 6 g-dose daily for 8 weeks. Intervention 4: Control group: This group received one capsule (placebo) similar to supplement L-citrulline for 8 weeks.</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:
A piece of data that contains information about variables that can be shared.

When:
Available period from 2022

To whom:
Researchers

Conditions:
Statistical analysis on the data is not allowed.

Where to obtain:
Amin Farzaneh Hesari
af.hessari@gmail.com

How to obtain:
The purposes and uses of the data should be clearly stated by the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amin Farzaneh Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Exercise Physiology, Sari Branch, Islamic Azad University, Farah Abad road</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>+98 11 3317 5333</telephone>
        <email>af.hessari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amin Farzaneh Hesari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of exercise physiology, Sari Branch, Islamic Azad University, Farah abad road</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816119318</zip>
        <telephone>+98 11 3317 5333</telephone>
        <email>af.hessari@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 60-75
Having general physical and mental health
Suffering from sarcopenia
Man</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Having a history of chronic disease
Inability to exercise
Having regular exercise history  (3 times a week, more than 30 minutes)
Drug use or supplementation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M62.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Muscle wasting and atrophy, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Exercise+Placebo: high intensity interval training performed for 8 weeks and 3 sessions per week that included 30 seconds cycling exercise on ergometer (intensity of 85-90% HR reserve). In addition, This group received one capsule  similar (placebo) to supplement L-citrulline for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: Supplement group: L-citrulline supplement consumed in single 6 g-dose daily for 8 weeks.</i_keyword>
      <i_keyword>Intervention group: Exercise+supplement group: participants of this group performed high intensity interval training performed for 8 weeks and 3 sessions per week that included 30 seconds cycling exercise on ergometer (intensity of 85-90% HR reserve). In addition, this group received L-citrulline supplement in single 6 g-dose daily for 8 weeks.</i_keyword>
      <i_keyword>Control group: This group received one capsule (placebo) similar to supplement L-citrulline for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum C-terminal agrin fragment peptide. Timepoint: Before and after eight weeks of intervention. Method of measurement: ELISA commercial kit.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance. Timepoint: Before and after eight weeks of intervention. Method of measurement: Romberg test.</sec_outcome>
      <sec_outcome>Muscular strength. Timepoint: Before and after eight weeks of intervention. Method of measurement: Dynamometer.</sec_outcome>
      <sec_outcome>Functional ability. Timepoint: Before and after eight weeks of intervention. Method of measurement: Timed up and go test.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-04-17</approval_date>
        <contact_name>Ethics committee of Islamic Azad University- Sari branch</contact_name>
        <contact_address>Department of Exercise Physiology, Islamic Azad University of Sari, Farah Abad Road Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
