<?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>IRCT20250410065276N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-25</date_registration>
      <primary_sponsor>The Shahid Bahonar University of Kerman</primary_sponsor>
      <public_title>The effect of 8 weeks Multi-Component program (VIVIFRAIL) on gait, balance and quality of life in the elderly with slight limitation</public_title>
      <acronym></acronym>
      <scientific_title>The effect of 8 weeks Multi-Component program (VIVIFRAIL) on gait, balance and quality of life in the elderly with slight limitation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-06-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82840</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: To select subjects in the first stage, explanations about the purpose of the research and its implementation will be provided orally to assess the participation of volunteers for cooperation. After receiving written consent, the individual and physical fitness of the participants will be assessed by completing questionnaires and interviews. Based on the results, those who did not meet the necessary conditions (such as a history of surgery or serious injury) were excluded from the study process. Finally, 34 people who are eligible for the study will be purposefully selected and, after a pre-test, will be randomly divided into two training and control groups (each group includes 17 people) through the RANDOM.ORG website.</study_design>
      <phase>N/A</phase>
      <hc_freetext>elderly with slight limitation.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Multi-component exercise program (resistance, flexibility, balance and gait) called VIVIFRAIL for 8 weeks, at least 3 sessions per week for 45-60 minutes. Intervention 2: Control group: This group will not do any exercise at the same time as the training group.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is No more information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Talai zade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Alley 25, Arnos Street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619647563</zip>
        <telephone>+98 34 3244 3468</telephone>
        <email>talaizade.maryam@gmail.com</email>
        <affiliation>Shahid Bahonar University of Kerman</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Talai zade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 2, Alley 25, Abnoos Street</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7619647563</zip>
        <telephone>+98 34 3244 3468</telephone>
        <email>talaizade.maryam@gmail.com</email>
        <affiliation>Shahid Bahonar university of Kerman</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a slight limitation in the screening test
Seniors 60 to 75 years old
Female gender
Obtaining informed consent from the elderly to participate in the study
No stroke or inner ear disorders
The answer to any of the questions on the Physical Activity Readiness Questionnaire (PARQ) is not yes.
Ability to walk independently</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>75 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Number of absences of more than 3 sessions during the protocol implementation process
Absence from pre-test and post-test
Sedatives or any type of medication that affects the subjects' balance or cognitive status</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>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Multi-component exercise program (resistance, flexibility, balance and gait) called VIVIFRAIL for 8 weeks, at least 3 sessions per week for 45-60 minutes.</i_keyword>
      <i_keyword>Control group: This group will not do any exercise at the same time as the training group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Spatial and temporal parameters of walking. Timepoint: At the beginning of the study and 3 days after completing the exercise protocol. Method of measurement: These parameters are evaluated by placing markers on the subjects' lower limbs and analyzing the video taken of walking with a Canon camera in the Kinovea software.</prim_outcome>
      <prim_outcome>Balance. Timepoint: At the beginning of the study and 3 days after completing the exercise protocol. Method of measurement: Mini-BESTest.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Balance and Coordination. Timepoint: At the beginning of the study and 3 days after completing the exercise protocol. Method of measurement: Six Spot Step Test.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: At the beginning of the study and 3 days after completing the exercise protocol. Method of measurement: Quality of Life Questionnaire (SF-36).</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>The Shahid Bahonar University of Kerman</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-02-15</approval_date>
        <contact_name>Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>University of Medical Sciences campus, beginning of Haft Bagh Alavi axis, Kerman Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
