<?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>IRCT20160523028028N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-15</date_registration>
      <primary_sponsor>Azarbaijan Shahid Madani University</primary_sponsor>
      <public_title>The Effect of physical activity with Respiratory Control on, Mental and Motor health of Elderly Stroke Patients</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Neuromuscular Exercises with Respiratory Control on Total Oxidant and Antioxidant Capacity, Mental and Motor Performance in Elderly Stroke Patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87466</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization method will be used. Allocation concealment will be conducted by a researcher not involved in the study. Opaque, identical, sealed envelopes will be prepared, containing the type of intervention according to a randomly generated allocation sequence. The envelopes, numbered from 1 to 30, will be distributed based on the order of participants entering the study, Blinding description: The outcome assessor will be blinded to the group differences in both pre-test and post-test phases. The data analyst will also be blinded to the group differences, and the groups will be entered into SPSS with codes 1 and 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to routine rehabilitation, participants performed combined exercises for 8 weeks, with three sessions per week, each lasting 60 to 90 minutes. Each session included a warm-up with stretching exercises (10 minutes), continuous walking on a line (10 to 15 minutes), fall-resistance training (15 to 20 minutes), PNF exercises for motor function (15 to 20 minutes), and a cool-down with breathing exercises during the final 15 to 20 minutes. Intervention 2: Control group:  Routine rehabilitation program (including initial assessment to check physical condition, Common physical exercises at the rehabilitation center, education and lifestyle changes, including nutrition modification, smoking cessation, and stress management).</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:
Data collection will be done by the researchers and information about the main outcomes of the study will be published

When:
Access to the data will be possible immediately after the results are printed

To whom:
The general public, athletic trainers, Stroke patients, and researchers

Conditions:
Reviewers of magazines and the Azarbaijan Shahid Madani University are allowed to send requests to receive non-identifiable personal data or other documents. Until the publication of the results in the form of an article, it is not allowed to perform statistical analysis on the delivered data.

Where to obtain:
Dr. Azam Zarneshan email: zarneshan@azaruniv.ac.ir

How to obtain:
via email to the corresponding author: Dr. Azam Zarnashan zarneshan@azaruniv.ac.ir

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Zarneshan آ</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Varzesh Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5541916777</zip>
        <telephone>+98 41 3145 2407</telephone>
        <email>zarneshan@azaruniv.ac.ir</email>
        <affiliation>Azarbaijan Shahid Madani University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Zarneshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Varzesh Ave</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5541916777</zip>
        <telephone>+98 41 3145 2407 1</telephone>
        <email>zarneshan@azaruniv.ac.ir</email>
        <affiliation>Azarbaijan Shahid Madani University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Achieving a score of 23 or higher on the cognitive status test and 30 to 44 on the Berg Balance Scale
, the ability to stand unassisted for at least eight minutes, walk without a cane
having at least a middle school education.
Patients with ischemic stroke</inclusion_criteria>
      <agemin>61 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Experiencing dizziness and difficulty standing during tests and exercises.
Uncontrolled epileptic seizures
Having Parkinson’s or other chronic diseases that cause balance and movement disorders during tests and exercises.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I63</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebral infarction</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In addition to routine rehabilitation, participants performed combined exercises for 8 weeks, with three sessions per week, each lasting 60 to 90 minutes. Each session included a warm-up with stretching exercises (10 minutes), continuous walking on a line (10 to 15 minutes), fall-resistance training (15 to 20 minutes), PNF exercises for motor function (15 to 20 minutes), and a cool-down with breathing exercises during the final 15 to 20 minutes.</i_keyword>
      <i_keyword>Control group:  Routine rehabilitation program (including initial assessment to check physical condition, Common physical exercises at the rehabilitation center, education and lifestyle changes, including nutrition modification, smoking cessation, and stress management)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Balance performance. Timepoint: Before and after 8 weeks of training protocol. Method of measurement: Berg Balance Scale.</prim_outcome>
      <prim_outcome>Total Oxidant Status (TOS). Timepoint: Before and after 8 weeks of training protocol. Method of measurement: ELISA ( TOS kit -Navan Salamat).</prim_outcome>
      <prim_outcome>Total Antioxidant Capacity (TAC). Timepoint: Before and after 8 weeks of training protocol. Method of measurement: ELISA (Naxifer™-Total Antioxidant Capacity Assay Kit-TAC).</prim_outcome>
      <prim_outcome>Vo2peak. Timepoint: Before and after 8 weeks of training protocol. Method of measurement: 6-Minute Walk Test.</prim_outcome>
      <prim_outcome>Isometric strength. Timepoint: Before and after 8 weeks of training protocol. Method of measurement: Dynamometer.</prim_outcome>
      <prim_outcome>Mental performance. Timepoint: Before and after 8 weeks of training protocol. Method of measurement: Mini-Mental State Examination.</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>Azarbaijan Shahid Madani University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-11-04</approval_date>
        <contact_name>کمیته اخلاق دانشگاه شهید مدنی آذربایجان</contact_name>
        <contact_address>خیابان ورزش تبریز East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
