<?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>IRCT20180627040260N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-27</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Effect  of Elastic Resistance Band Training on Biomarkers of Osteosarcopenia obesity</public_title>
      <acronym></acronym>
      <scientific_title>The  Study of  Effect of a 24-Weeks Period of Elastic Resistance Band Training on Biomarkers of Osteosarcopenia Obesity in Osteosarcopenic Obese Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32463</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After completing the initial evaluations, subjects are randomly assigned to the training or control group in a 1: 1 ratio using block randomization based on age (60 to 80 years) (stratified blocked randomization) using Unspecified seal envelopes are assigned. A research assistant, not directly involved in the evaluation, generates block size and random sequences using a computer that is hidden from the study researcher.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oosteo sarcopenic obesity syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Individuals in the intervention group participate in a special training program. Participants in both groups are asked to continue their previous diet. The personalized training program using rubber bands (Thera-Band®, The Hygenic Corporation, Akron, OH, USA) is a two training sessions per week course for the duration of 24 weeks which leads to a total of 48 sessions. The program will include 10 minute warm-up and cool down stretching exercises at the beginning and end of each training session. Each session will be a 60 minute resistance training using rubber bands (the extent and intensity of exercise will be increased over the time). Intend resistance exercises will be the alternative training of upper and lower body large muscles. Using rubber bands will cause the needed resistance overload. This type of resistance loading is chosen for both ease of use and performance, also it is suitable for elderly people who did not previously engage in physical activities. Intensity of loading was adjusted using color coded rubber bands (based on strengths yellow, red, green and blue). Intensity of initial resistance load for each individual was chosen based on their ability to do 15-20 repetitions. Each two weeks the training program is reviewed and if the individuals can do 30 repetitions the strength of rubber band will be increased. Each resistance session of training with rubber bands would also include exercising one or two groups of major muscles (legs, back, stomach, chest, shoulders, and arms). These exercises include: seated rowing exercise, standing body rotation, squat, leg press, crunching, preacher curls with two hands, lateral flexion, triceps extension, bench press, and dorsiflexion of ankles. Completion of all ten mentioned exercises is counted as one cycle. To induce standard resistance, rubber band should be stretched to 100% of rest lengths. Training speed of each internal and external phase of sessions should be 4seconds. Each session consists of 3 cycles. Intervention 2: Control group: The control group only performs daily activities.Participants are asked to continue their past food program.</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:
In the form ofThesis

When:
1397

To whom:
For all audiences

Conditions:
For all audiences

Where to obtain:
Shahrekord Medical University

How to obtain:
In the form ofThesis

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ebrahim Banitalebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rahbar Blvd, Shahrekord University,</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۴۱۴۱۸۸۱۸۶</zip>
        <telephone>+98 383232440</telephone>
        <email>banitalebi.e@gmail.com</email>
        <affiliation>The University of Shahrekord</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadali Dayani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Parastar  Street,Shariati Blvd,Shahrekord,Chaharmahal &amp; Bakhtiari Province</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۸۱۶۷۵۸۹۱۵</zip>
        <telephone>+98 38 3224 4194</telephone>
        <email>dayani@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 65 years old,
Fat percentage greater than 32% or BMI greater than 30%,
T-score &lt; -1.0,
The power of the Handgrip Strength is less than 21kg,
Age range of 65 to 80 years</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>80 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Chronic diseases such as high blood pressure, thyroid disease, severe kidney disease, cancer, diabetes or ,osteoporosis (T-score &lt; -2.5)
Parallel Physical Exercises
Following a weight loss diet of more than 5kg in the last three months
Hormone therapy or taking any medication that affects bone density, fat tissue, or hormonal system.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Individuals in the intervention group participate in a special training program. Participants in both groups are asked to continue their previous diet. The personalized training program using rubber bands (Thera-Band®, The Hygenic Corporation, Akron, OH, USA) is a two training sessions per week course for the duration of 24 weeks which leads to a total of 48 sessions. The program will include 10 minute warm-up and cool down stretching exercises at the beginning and end of each training session. Each session will be a 60 minute resistance training using rubber bands (the extent and intensity of exercise will be increased over the time). Intend resistance exercises will be the alternative training of upper and lower body large muscles. Using rubber bands will cause the needed resistance overload. This type of resistance loading is chosen for both ease of use and performance, also it is suitable for elderly people who did not previously engage in physical activities. Intensity of loading was adjusted using color coded rubber bands (based on strengths yellow, red, green and blue). Intensity of initial resistance load for each individual was chosen based on their ability to do 15-20 repetitions. Each two weeks the training program is reviewed and if the individuals can do 30 repetitions the strength of rubber band will be increased. Each resistance session of training with rubber bands would also include exercising one or two groups of major muscles (legs, back, stomach, chest, shoulders, and arms). These exercises include: seated rowing exercise, standing body rotation, squat, leg press, crunching, preacher curls with two hands, lateral flexion, triceps extension, bench press, and dorsiflexion of ankles. Completion of all ten mentioned exercises is counted as one cycle. To induce standard resistance, rubber band should be stretched to 100% of rest lengths. Training speed of each internal and external phase of sessions should be 4seconds. Each session consists of 3 cycles.</i_keyword>
      <i_keyword>Control group: The control group only performs daily activities.Participants are asked to continue their past food program</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Troponin t. Timepoint: 24 hours before the intervention and 48 hours after the end of the workout. Method of measurement: ELISA KIT,96 WELLS.</prim_outcome>
      <prim_outcome>Sclerostin. Timepoint: 24 hours before the intervention and 48 hours after the end of the workout. Method of measurement: ELISA KIT,96 WELLS.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-22</approval_date>
        <contact_name>Ethics Committee of Shahrekord University of Medical Sciences</contact_name>
        <contact_address>Educational Complex of Shahrekord University of Medical Sciences, Rahmatieh,Shahrekord Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
