<?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>IRCT20230619058528N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-10</date_registration>
      <primary_sponsor>Arak University</primary_sponsor>
      <public_title>The effect of locomotor training and aerobic exercise on elderly people with locomotive syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of locomotor training and aerobic exercise on balance, fear of falling, and lower limb strength in elderly women locomotive syndrome</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/82534</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: The research population will consist of 45 women aged 60 and above with Locomotor syndrome. The number of samples was obtained using G-power software for each of the three groups of 45 people (locomotor exercises combined with aerobic exercises (15 people), locomotor exercises (15 people), and control (15 people)). The groups will be selected by simple random selection, Blinding description: Participants are unaware of the division into control and experimental groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Locomotive syndrome.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1: Locomotor Exercises Combined with Aerobic ExercisesThe locomotor exercises include four types of movements:1. Single-leg stance: This exercise is performed for one minute. If the elderly participants feel unsteady, they can hold onto a chair for support.2. Squats: Performed by bending the knees to a 90-degree angle while holding onto a chair for support. This exercise is done in three sets of six repetitions.3. Heel raises: Executed in three sets of ten repetitions, with a four-count lift and a four-count lower.4. Forward lunges: Taking a step forward as far as possible while maintaining an upright posture. This exercise is performed in three sets of five repetitions.Aerobic exercises for the elderly include activities with low to moderate intensity (40–70% of maximum heart rate) to improve cardiorespiratory endurance, strengthen muscles, and maintain joint flexibility. This section includes:5 minutes of warm-up20 minutes of brisk walking5 minutes of recoveryThese exercises will be conducted for 8 weeks, three sessions per week, with 15 participants. Intervention 2: Intervention Group 2: (Locomotor Exercises)These exercises include four types of movements:1. Single-leg stance: This exercise is performed for one minute. If the elderly participants feel unsteady, they can hold onto a chair for support.2. Squats: Performed by bending the knees to a 90-degree angle while holding onto a chair for support. This exercise is done in three sets of six repetitions.3. Heel raises: This exercise is performed in three sets of ten repetitions with a four-count lift and a four-count lower.4. Forward lunges: Taking a step forward as far as possible while maintaining an upright posture. This exercise is performed in three sets of five repetitions.These exercises will be conducted for 8 weeks, three sessions per week, and with 15 participants. Intervention 3: Control Group:This group will include 15 participants who will not receive any intervention for 8 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahnaz Shahrjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Karbala Boulevard, Basij Square, Sardasht, Arak University, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 902 432 6286</telephone>
        <email>shahjerdi_shahnaz@gmail.com</email>
        <affiliation>Arak University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahnaz Shahrjerdi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Sports Sciences, Department of Sports Physiology and Pathology, Karbala Boulevard, Basij Square, Sardasht, Arak University, Arak</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3848177584</zip>
        <telephone>+98 902 432 6286</telephone>
        <email>shahjerdi_shahnaz@gmail.com</email>
        <affiliation>دانشگاه اراک</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly women with Locomotor syndrome, 60 years and older
Having individual independence in personal and health matters
No history of lower limb surgery within the past 2 years.
No history of degenerative joint diseases</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Inability to perform daily activities and health care
History of fractures and surgery in the lower extremities within the last 2 years
Elderly people with MS or Parkinson's disease
Absence of more than 3 training sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G12.29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other motor neuron disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group 1: Locomotor Exercises Combined with Aerobic ExercisesThe locomotor exercises include four types of movements:1. Single-leg stance: This exercise is performed for one minute. If the elderly participants feel unsteady, they can hold onto a chair for support.2. Squats: Performed by bending the knees to a 90-degree angle while holding onto a chair for support. This exercise is done in three sets of six repetitions.3. Heel raises: Executed in three sets of ten repetitions, with a four-count lift and a four-count lower.4. Forward lunges: Taking a step forward as far as possible while maintaining an upright posture. This exercise is performed in three sets of five repetitions.Aerobic exercises for the elderly include activities with low to moderate intensity (40–70% of maximum heart rate) to improve cardiorespiratory endurance, strengthen muscles, and maintain joint flexibility. This section includes:5 minutes of warm-up20 minutes of brisk walking5 minutes of recoveryThese exercises will be conducted for 8 weeks, three sessions per week, with 15 participants.</i_keyword>
      <i_keyword>Intervention Group 2: (Locomotor Exercises)These exercises include four types of movements:1. Single-leg stance: This exercise is performed for one minute. If the elderly participants feel unsteady, they can hold onto a chair for support.2. Squats: Performed by bending the knees to a 90-degree angle while holding onto a chair for support. This exercise is done in three sets of six repetitions.3. Heel raises: This exercise is performed in three sets of ten repetitions with a four-count lift and a four-count lower.4. Forward lunges: Taking a step forward as far as possible while maintaining an upright posture. This exercise is performed in three sets of five repetitions.These exercises will be conducted for 8 weeks, three sessions per week, and with 15 participants.</i_keyword>
      <i_keyword>Control Group:This group will include 15 participants who will not receive any intervention for 8 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dynamic balance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Time to get up and go test.</prim_outcome>
      <prim_outcome>Static balance. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Four-Step Balance Test (FsBT).</prim_outcome>
      <prim_outcome>Fear of falling. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Fear of Falling Questionnaire (FES-I).</prim_outcome>
      <prim_outcome>Lower limb strength. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: 30-second sit-to-stand test (30sCST).</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>Arak University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-03-12</approval_date>
        <contact_name>Ethics committee of Arak University</contact_name>
        <contact_address>Arak University, Karbala Boulevard,  Basij Square,  Sardasht, Arak Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
