<?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>IRCT20220919055988N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-28</date_registration>
      <primary_sponsor>Kharazmi University</primary_sponsor>
      <public_title>The effect of corrective exercise with massage on balance, motor function, gait and quality of life of the elderly male with hyperkyphosis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of corrective exercise with massage on balance, motor function, gait and quality of life of the elderly male with hyperkyphosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66223</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized into two groups (one intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Hypokyphosis. Condition 2: strengthening exercises.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Corrective exercises and massage therapy were considered for each subject and three sessions were held for 8 weeks. the duration of each session was 6 min, including 10 minutes of warming up and cooling down. Intervention 2: Control group:  without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 43. South Mofatteh Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15719-14911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>Hassan.sadeghi81@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Hadadnezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 43. South Mofatteh Ave., Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15719-14911</zip>
        <telephone>+98 21 8832 9220</telephone>
        <email>m.hadadnezhad@yahoo.com</email>
        <affiliation>Kharazmi University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Hyperkyphosis above 40 degrees
Age range from 65 to 74 years
The ability to stand for at least 1 minute and walk 10 meters or more independently or with a regular cane. The doctor's permission to participate in this study and the ability to perform corrective movements.
Not taking sedatives or any special medicine affecting balance
Not having any uncontrollable neurological, severe respiratory, vascular, metabolic and musculoskeletal diseases
Not having any severe and serious visual or hearing impairment</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>74 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Major psychiatric disease, cognitive disorder
Alcohol or drug abuse
The presence of any physical defect affecting balance activities
Having a history of sprained joints, having a history of hip, knee and ankle joint surgery
Presence of acute cardio-respiratory diseases
Existence of chronic diseases of the motor system (joint rheumatism, chronic arthritis and osteoporosis) (confirmed by a specialist doctor)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M40</hc_code>
      <hc_code>Y93.B9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Kyphosis and lordosis</hc_keyword>
      <hc_keyword>Activity, other involving muscle strengthening exercises</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Corrective exercises and massage therapy were considered for each subject and three sessions were held for 8 weeks. the duration of each session was 6 min, including 10 minutes of warming up and cooling down.</i_keyword>
      <i_keyword>Control group:  without any intervention. During this period, the control group asked to perform routine daily activities and not participate in specific exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kyphosis status: In this study, the outcome of the first variable is the reduction of the kyphosis angle. Timepoint: Measurement of thoracic kyphosis at the beginning of the study (pre-test), measurement again at the end of the study (post-test). Method of measurement: Flexible ruler.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dynamic balance. Timepoint: At the beginning of the study (before the start of the intervention), (pre-test), and at the end of the intervention, (post-test). Method of measurement: In this research, dynamic balance during movement will be measured by TUG.</sec_outcome>
      <sec_outcome>Motor performance factor. Timepoint: At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test). Method of measurement: 6-minute walking test to measure motor performance.</sec_outcome>
      <sec_outcome>Walking item. Timepoint: At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test. Method of measurement: 2D imaging for gait assessment.</sec_outcome>
      <sec_outcome>Quality of life factor. Timepoint: At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test). Method of measurement: The SF_36 questionnaire was used to evaluate the quality of life.</sec_outcome>
      <sec_outcome>Static balance. Timepoint: At the beginning of the study, before the intervention (pre-test), at the end of the intervention (post-test). Method of measurement: Sharpendermberg test to measure static balance.</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>Kharazmi University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-20</approval_date>
        <contact_name>Sport Sciences Research Institute (SSRI)</contact_name>
        <contact_address>No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
