<?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>IRCT20150519022320N29</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-21</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of Otago exercises and chair squat under supervision at home on the fear of falling and the quality of life of the elderly.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Otago exercises and chair squat under supervision at home on the fear of falling and the quality of life of the elderly referring to Rafsanjan comprehensive health centers in 2023.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71409</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: After determining the samples, the data will be divided into 3 groups A, B, and C according to age and sex, in such a way that the first data in one of the 3 groups will be divided by a simple random method and using the "Random allocation software" are selected and and in the next 2 groups, the data is allocated in the same way based on the software. After allocating the data equally to 3 groups, treatment methods were written on 3 separate sheets and a method will be assigned to each group by lottery, and the intervention groups of Otago exercise and Chair Squat exercise and the Control group will be determined.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Fear of falling. Condition 2: Quality of Life.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The Otago exercise intervention group with one of their family members participates in an orientation session and the exercise protocol is taught by the researcher using training handbook and videos, and at the end of the session, all the elderly are assessed one by one in terms of correct performance of exercises. Then, for 8 weeks, 3 sessions a week and each session lasts 45 minutes at home, they do Otago exercises according to the training method. During the study, all the participants are monitored through virtual groups in which the elderly themselves or one of their family members who attended the briefing session are members, as well as telephone follow-ups, and they can raise their questions and problems. Each session exercises is reminded and monitored, and if possible, training videos of the exercises are also shared for them. Intervention 2: Intervention group: The Chair squat exercise intervention group with one of their family members participates in an orientation session and the exercise protocol is taught by the researcher using training handbook and videos, and at the end of the session, all the elderly are assessed one by one in terms of correct performance of exercises. Then, for 8 weeks, 3 sessions a week and each session lasts 45 minutes at home, they do Chair squat exercises according to the training method. During the study, all the participants are monitored through virtual groups in which the elderly themselves or one of their family members who attended the briefing session are members, as well as telephone follow-ups, and they can raise their questions and problems. Each session exercises is reminded and monitored, and if possible, training videos of the exercises are also shared for them. Intervention 3: Control group: In the control group with the same conditions as the intervention groups, there is no intervention and they continue their usual daily activities.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Tayebeh Mirzaei, KHalil Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Tayebeh Mirzaei, KHalil Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>T.Mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being over 60 years old
Obtaining an average score of 10 from the SAFFE questionnaire
Having a low average quality of life based on the SF-36 questionnaire
Not having a severe hearing problem
Not having severe vision problems
Not having physical and mental problems that prevent movements
Not suffering from diseases such as stroke, dementia, multiple sclerosis, orthopedic problems, as well as taking medications that cause balance disorders and fear of falling (obtaining information through interviews and examining the health status of the elderly)
Complete mastery of the Persian language
Not living in a nursing home or other institutions
Not having an activity prohibition order from the doctor
No having disability</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of spine fracture and vertebral and orthopedic problems
Having a regular exercise program in the previous 6 months
Having health problems affecting doing exercises at home such as heart disorder, brain disorder, dyspnea, arrhythmia
Chronic use of knee braces, crutches, walkers and wheelchairs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The Otago exercise intervention group with one of their family members participates in an orientation session and the exercise protocol is taught by the researcher using training handbook and videos, and at the end of the session, all the elderly are assessed one by one in terms of correct performance of exercises. Then, for 8 weeks, 3 sessions a week and each session lasts 45 minutes at home, they do Otago exercises according to the training method. During the study, all the participants are monitored through virtual groups in which the elderly themselves or one of their family members who attended the briefing session are members, as well as telephone follow-ups, and they can raise their questions and problems. Each session exercises is reminded and monitored, and if possible, training videos of the exercises are also shared for them.</i_keyword>
      <i_keyword>Intervention group: The Chair squat exercise intervention group with one of their family members participates in an orientation session and the exercise protocol is taught by the researcher using training handbook and videos, and at the end of the session, all the elderly are assessed one by one in terms of correct performance of exercises. Then, for 8 weeks, 3 sessions a week and each session lasts 45 minutes at home, they do Chair squat exercises according to the training method. During the study, all the participants are monitored through virtual groups in which the elderly themselves or one of their family members who attended the briefing session are members, as well as telephone follow-ups, and they can raise their questions and problems. Each session exercises is reminded and monitored, and if possible, training videos of the exercises are also shared for them.</i_keyword>
      <i_keyword>Control group: In the control group with the same conditions as the intervention groups, there is no intervention and they continue their usual daily activities.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Elderly Fear of falling. Timepoint: All participants will complete the SAFFE fear of falling questionnaire before and one month after the end of the intervention. Method of measurement: SAFFE fear of falling questionnaire.</prim_outcome>
      <prim_outcome>Elderly quality of life. Timepoint: All participants will complete the SF-36 quality of life questionnaire before  and one month after the end of the intervention. Method of measurement: SF-36 Quality of life questionnaire.</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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-19</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse Avenue, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
