<?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>IRCT20230727058944N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-09-20</date_registration>
      <primary_sponsor>Allameh Tabataba'i University</primary_sponsor>
      <public_title>Effect of exercise training on sarcopenia in elderlies</public_title>
      <acronym>TRX (Total Body Resistance Exercise)</acronym>
      <scientific_title>The effects of TRX Suspension Training on sarcopenic neuromuscular markers and functional abilities in elderlies with sarcopenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71635</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>With aging, there is an inevitable progressive loss of muscle mass and strength called sarcopenia that is associated with the risk of impairment in physical ability which could lead to consequences such as falls, fall-related injuries, hospitalizations, and even mortality..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: TRX training group: Participants were trained for 8 weeks, three sessions per week, and about 60 min per session. Intervention 2: Control group: Participants in the Control group were asked to continue their routine lifestyle.</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:
All data is shareable after de-identifying individuals.

When:
starting 6 months after publication

To whom:
The data will be available to researchers working in academic and scientific institutions and people who work in businesses.

Conditions:
Any use and analysis of data must be done in coordination with the researcher of this project.

Where to obtain:
Applicants can send their requests to receive data to sohrabrezaei8968@gmail.com.

How to obtain:
After sending the request, the person's profile and purpose for receiving the data will be asked, and the documents will be sent after confirmation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasoul Eslami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Address: Allameh Tabataba'i University, Varzesh Sq., Dehkadeh Olympic, Tehran, Iran.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>14896845110</zip>
        <telephone>+98 918 366 4507</telephone>
        <email>eslami.rasul@gmail.com</email>
        <affiliation>Allameh Tabataba'i University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sohrab Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.18, Homayoun St., Dastgerdi St. Shariati Ave.,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1919843861</zip>
        <telephone>+98 21 2291 2865</telephone>
        <email>sohrabrezaei8968@gmail.com</email>
        <affiliation>Allameh Tabataba'i University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age more than 65 years
Handgrip strength lower than 32Kg
SMM/height2 lower than 9.2 kg/m2
Being sedentary for at least 1 year (didn’t have more than 1h exercise per week)</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Cardiovascular or pulmonary diseases, diabetes, Joint and muscle problems, and Mental and cognitive disorders
Involvement in any extra exercise training programs
Not interested to continue or change in personal life schedule</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>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: TRX training group: Participants were trained for 8 weeks, three sessions per week, and about 60 min per session.</i_keyword>
      <i_keyword>Control group: Participants in the Control group were asked to continue their routine lifestyle.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Myostatin levels. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: Collection of venous blood samples with a syringe and laboratory assessments.</prim_outcome>
      <prim_outcome>Follistatin levels. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: Collection of venous blood samples with a syringe and laboratory assessments.</prim_outcome>
      <prim_outcome>GDF-15 levels. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: Collection of venous blood samples with a syringe and laboratory assessments.</prim_outcome>
      <prim_outcome>CAF levels. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: Collection of venous blood samples with a syringe and laboratory assessments.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Handgrip strength. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: Jamar hand dynamometer (USA) with five handle positions and the second position was used for all participants.</sec_outcome>
      <sec_outcome>Gait speed. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: Walking speed of participants was assessed using a stopwatch.</sec_outcome>
      <sec_outcome>Time Up and Go (TUG). Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: TUG test was assessed using a stopwatch.</sec_outcome>
      <sec_outcome>Chair stand speed. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: chair stand test was assessed using a stopwatch.</sec_outcome>
      <sec_outcome>Standing balance. Timepoint: 24 hours before intervention and 48 hours after intervention. Method of measurement: The standing balance test was assessed using a stopwatch.</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>Allameh Tabataba'i University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-01-15</approval_date>
        <contact_name>Ethics committees of Allameh Tabataba'i University</contact_name>
        <contact_address>Floor 13, Block A, Ministry of Health &amp; Medical Education Headquarters, Between Zarafashan &amp; South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
