<?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>IRCT20221120056548N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-01</date_registration>
      <primary_sponsor>Danesh Alborz University</primary_sponsor>
      <public_title>Effect of exercise, vitamin D supplementation on serum levels of alkaline phosphatase and reactive protein(crp)</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks of combined exercises with and without blood flow restriction and vitamin D intake on serum levels of alkaline phosphatase and C reactive exercise (crp) and muscle quality of elderly women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68774</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: By referring to the rehabilitation and physiotherapy clinic, eligible people were identified and placed in the intervention groups using equal blocks (10 blocks of 4) randomization. In this randomization, the method of equal blocks (10 blocks of 4) was used, in which a number of intervention people and a number of comparison people are included in each block, and we assigned them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Elderly.</hc_freetext>
      <i_freetext>Intervention group: combined exercises (aerobic-resistance) of an 8-week program will include three training sessions per week and about one hour per day. Before starting the exercise, the subjects warm up for 10 minutes with stretching and stretching movements, and at the end of the exercise, they cool down with stretching movements for 10 minutes. Resistance exercises include two lower body movements (leg press, knee extension) and two upper body movements (front arm, back arm). Leg, front thigh, front arm and back arm press movements with intensity (80% of one maximum repetition) three sets with 8-12 repetitions for the first group and intensity of 20-30% of one maximum repetition (three sets until exhaustion) for groups The second and third work is done with weights. In the subjects of the third group, blood flow restriction is done by closing the elastic bands in the proximal part of both legs during lower body exercises or both arms during upper body exercises. In the supplement group, vitamin D supplement in the form of 50,000 mg capsules will be used once every two 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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
It will be available for researchers working in academic and scientific institutions.

Conditions:
If the intellectual rights are preserved, the data can be sent to the researchers.

Where to obtain:
Email address: saeidshamlou9092@gmail.com

How to obtain:
Submission of a written request (one week)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Shamlou Kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdiyeh AVE</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3221 0929</telephone>
        <email>saeidshamlou9092@gmail.com</email>
        <affiliation>Bu-Ali Sina University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Shamlou kazemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mahdiyeh street</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838695</zip>
        <telephone>+98 81 3221 0929</telephone>
        <email>saeidshamlou9092@gmail.com</email>
        <affiliation>Bu-Ali Sina university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>elderly</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>History of cardiovascular disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O09.52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>elderly</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: combined exercises (aerobic-resistance) of an 8-week program will include three training sessions per week and about one hour per day. Before starting the exercise, the subjects warm up for 10 minutes with stretching and stretching movements, and at the end of the exercise, they cool down with stretching movements for 10 minutes. Resistance exercises include two lower body movements (leg press, knee extension) and two upper body movements (front arm, back arm). Leg, front thigh, front arm and back arm press movements with intensity (80% of one maximum repetition) three sets with 8-12 repetitions for the first group and intensity of 20-30% of one maximum repetition (three sets until exhaustion) for groups The second and third work is done with weights. In the subjects of the third group, blood flow restriction is done by closing the elastic bands in the proximal part of both legs during lower body exercises or both arms during upper body exercises. In the supplement group, vitamin D supplement in the form of 50,000 mg capsules will be used once every two weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of elderly people in the community with improvement of alkaline phosphatase level. Timepoint: Measurement of alkaline phosphatase levels before and after the intervention. Method of measurement: ALP bone isozyme test.</prim_outcome>
      <prim_outcome>The percentage of elderly people in the community with decreased levels of reactive protein. Timepoint: Measurement of reactive protein levels before and after the intervention. Method of measurement: By testing blood samples.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Danesh Alborz University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-27</approval_date>
        <contact_name>Ethics Committee of Sports Science Research Institute</contact_name>
        <contact_address>Fifth Alley, Mir Emad Ave., Ostad Motahari Ave Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
