<?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>IRCT20201030049193N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-03</date_registration>
      <primary_sponsor>Univercity of Bojnord</primary_sponsor>
      <public_title>Effect of massed vs. distributed lower body strength training on whole body function</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of massed vs. distributed lower body strength training on whole body function in elderly women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56171</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Three groups of female participants will be randomly recruited to participate in this study. The block randomization method will be used to create a random sequence to assign participants randomly in one of the three groups. In this method, blocks of 6 all possible combinations (8 modes) are created, then these blocks are numbered and randomly selected and placed one after the other, and thus, participants will be assigned into two groups A and B ( as intervention), and group C (as control), Blinding description: In order for single blinding, some general information about how to perform the training and testing methods will be given to all the participants. However no information will be provided to the participants on which training group they will be placed in.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Distributed and massed strength training of the lower body, whole body function (lower and upper body).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Consisting of 15 participants who will be training using a distributed strength program, including 5 sessions per week and each session will be 45-60 minutes of training. The principle of overload will be considered for all the 12 weeks of training.This program consists of three parts: warm-up for lower limbs (part I), 10-minute of general stretching movements. Strength training of lower limbs (part II), The program in the first month of training will be based on the individual's weight, the second month with low resistance  stretch bands, the third month with medium and high resistance stretch bands. A cool down (part III), consisting of 10 minutes  walking, standing and sitting stretching movements will finally be completed. Intervention 2: Intervention group 2: Consisting of 15 participants will be training in a  massed strength training protocol. The protocol includes 3 sessions per week and each session will be 45-60 minutes of training. The principle of overload will be considered for all the 12 weeks of training.This program consists of three parts: warm-up for lower limbs (part I), including 10-minute stretching movements. Strength training of the lower body limbs (part II), The first month training will be implemented based on the individual's weight, the second month with low resistance stretch bands, the third month with medium and high resistance stretch bands. A cooling  down (part III) program, including 10 minutes  walking, standing and sitting stretching movements will finally be completed. Intervention 3: Control group:  Consisting of a group of 15 participants who will continue to their regular daily living but will attend to the three sessions of pre, mid, and post test 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
We share data files including personal information and data related to pre-test and post-test in a coded and unanimous folder by the person in charge, Dr. Mehdi Hosseinzadeh, on the website of Bojnord University.

When:
Start the access period as soon as the results are published

To whom:
It will be available to all research groups as well as all other people who are interested

Conditions:
The data can be used for further studies as well as in all research groups, and any kind of research analysis and use is allowed on the data, and under the conditions that the person use it should refer to us (the paper published), this data will be provided to them.

Where to obtain:
Refer to the person responsible for answering Dr. Mehdi Hosseinzadeh: Address: No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran, Iran Sport Science Researcher Institute Postal Code 1587958711 Email: metti@ssrc.ac.ir Phone: 009877146478 : 00988739092

How to obtain:
The applicant will send his/her application to the e-mail address of Dr. Mehdi Hosseinzadeh (metti@ssrc.ac.ir) and Dr. Hosseinzadeh will provide the information to his/her after the necessary checks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 5th Ahhey, Miremad Street, Motahhari Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1587958711</zip>
        <telephone>+98 21 7714 6478</telephone>
        <email>metti@ssrc.ac.ir</email>
        <affiliation>Sport Sciences Research Institute of Iran</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Hosseinzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 5th Ahhey, Miremad Street, Motahhari Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1587958711</zip>
        <telephone>+98 21 7714 6478</telephone>
        <email>metti@ssrc.ac.ir</email>
        <affiliation>Sport Sciences Research Institute of Iran</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>women who are 55 years old and/or older
Having no regular training over the past six months</inclusion_criteria>
      <agemin>55 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a history of falling
Having joint and physiological problems</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>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Consisting of 15 participants who will be training using a distributed strength program, including 5 sessions per week and each session will be 45-60 minutes of training. The principle of overload will be considered for all the 12 weeks of training.This program consists of three parts: warm-up for lower limbs (part I), 10-minute of general stretching movements. Strength training of lower limbs (part II), The program in the first month of training will be based on the individual's weight, the second month with low resistance  stretch bands, the third month with medium and high resistance stretch bands. A cool down (part III), consisting of 10 minutes  walking, standing and sitting stretching movements will finally be completed.</i_keyword>
      <i_keyword>Intervention group 2: Consisting of 15 participants will be training in a  massed strength training protocol. The protocol includes 3 sessions per week and each session will be 45-60 minutes of training. The principle of overload will be considered for all the 12 weeks of training.This program consists of three parts: warm-up for lower limbs (part I), including 10-minute stretching movements. Strength training of the lower body limbs (part II), The first month training will be implemented based on the individual's weight, the second month with low resistance stretch bands, the third month with medium and high resistance stretch bands. A cooling  down (part III) program, including 10 minutes  walking, standing and sitting stretching movements will finally be completed.</i_keyword>
      <i_keyword>Control group:  Consisting of a group of 15 participants who will continue to their regular daily living but will attend to the three sessions of pre, mid, and post test sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lower body strength performance evaluated by hamstring and quadriceps muscles strength. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Digital dynamo-meter device made in Iran, 30 second chair stand test.</prim_outcome>
      <prim_outcome>Strength of the upper body limbs, Biceps muscles. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Digital dynamo-meter device made in Iran, 30 second arm Curl Test.</prim_outcome>
      <prim_outcome>Proprioception of the Knee joint, and elbow joint. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Plastic goniometer with accuracy of measuring at least 1 degree.</prim_outcome>
      <prim_outcome>Functional Gait Assessment. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Optogait recording with a frequency of 1000 Hz and an accuracy of 1 cm Made in Italy, 10 m walking test.</prim_outcome>
      <prim_outcome>Pain score. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Visual Analogue Scale, Timed 10-stair climbing and descending.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Digital Sphygmomanometer.</prim_outcome>
      <prim_outcome>Anthropometric indices. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Weight measurement using a digital scale made in China with an accuracy of 100 grams. Measuring the circumference of the arm, forearm, thigh, leg using a tape meter made in Iran with an accuracy of 0.1 cm. Body composition recorded using the BIA101 BIVA Akren made in Italy.</prim_outcome>
      <prim_outcome>Resting heart rate. Timepoint: The outcome measures will be recorded at three time points including a baseline- pretest measurements at the start of the study, a mid test session after eighth weeks of training and finally a post test which will be recorded after finishing the training after the week twelve. Method of measurement: Digital Sphygmomanometer.</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>Univercity of Bojnord</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-04-12</approval_date>
        <contact_name>Ethics Committee of Sport Sciences Reseatch Institute</contact_name>
        <contact_address>No. 3,Fifth, Mir Emad St.,Ostad Motahari St Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
