<?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>IRCT20241009063315N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-05-27</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of exercise on Parkinson's disease</public_title>
      <acronym></acronym>
      <scientific_title>The effect of eight weeks of combination of Frankel and Cawthorne Cooksey exercises on physical and Psychological Function of patients with parkinson disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79563</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, 30 patients were selected as a sample through a convenient and purposeful method (scores one to three based on the Hoon and Yar scale) and were randomly and pairedly divided into two experimental and control groups of fifteen people based on the Hoehn and Yahr scale.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Parkinson's disease.</hc_freetext>
      <i_freetext>Intervention 1: The first group: the training group that did Cawthorne Cooksey and Frankel combined exercises for 2 months three sessions a week and each one hour session under the supervision of a corrective movement trainer and a neurologist.Each training session consisted of a 10-minute warm-up, 20 minutes of Cawthorne-cooksey exercises, 20 minutes of Frankel exercises, and a 10-minute cool-down.Frankel exercises are an exercise method that focuses on the lower extremities and improves balance and coordination, and involve a series of slow, repetitive movements performed in sitting, standing, and lying positions. Cawthorne-cooksey exercises are part of the vestibular exercises that lead to improved balance. Intervention 2: Control group: second group: who went about their usual life and taking medicines.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 1 month after the results are published

To whom:
university professors

Conditions:
If you bring the name of the researcher and give a reference

Where to obtain:
Send a message to my email.

How to obtain:
About 1 to 2 weeks

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholam Ali Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Isfahan University, Faculty of Sports Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>0098 31-3793257</telephone>
        <email>gh.ghasemi@spr.ui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholam Ali Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi Square, Isfahan University, Faculty of Sports Sciences</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673441</zip>
        <telephone>+98 31 3793 2571</telephone>
        <email>Gh.ghasemi@spr.ui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 60 to 80 years old
Suffering from Parkinson's disease (score 1-3 based on Hoehn and Yahr scale)
Voluntary consent to participate in research
Absence of other neurological and musculoskeletal diseases</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of surgery or fracture in the lower limb
Participate in the program Physical exercise at the same time as conducting research
Not participating regularly in training sessions (absence in five alternating sessions or three consecutive sessions)
Not completing research tests
Unforeseen circumstances that occur prevent the patient from participating in the research
Voluntary withdrawal from participation in research
Diseases and disorders of the inner ear (vestibular system)
Having other neurological diseases other than Parkinson's, such as MS, Alzheimer's, etc.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Parkinson's disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first group: the training group that did Cawthorne Cooksey and Frankel combined exercises for 2 months three sessions a week and each one hour session under the supervision of a corrective movement trainer and a neurologist.Each training session consisted of a 10-minute warm-up, 20 minutes of Cawthorne-cooksey exercises, 20 minutes of Frankel exercises, and a 10-minute cool-down.Frankel exercises are an exercise method that focuses on the lower extremities and improves balance and coordination, and involve a series of slow, repetitive movements performed in sitting, standing, and lying positions. Cawthorne-cooksey exercises are part of the vestibular exercises that lead to improved balance.</i_keyword>
      <i_keyword>Control group: second group: who went about their usual life and taking medicines.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The effect of exercise protocol on static balance in patients with Parkinson's disease. Timepoint: Static balance was measured first before the start of training and then after two months of training. Method of measurement: Sharpend Romberg test.</prim_outcome>
      <prim_outcome>Determining the effect of exercise protocol on dynamic balance in patients with Parkinson's disease. Timepoint: Dynamic balance was measured first before the start of training and then after two months of training. Method of measurement: Timed up and Go test.</prim_outcome>
      <prim_outcome>Determining the effect of exercise protocol on muscle strength in patients with Parkinson's disease. Timepoint: Muscle strength was measured first before the start of training and then after two months of training. Method of measurement: Digital hand-held dynamometer.</prim_outcome>
      <prim_outcome>Determining the effect of the exercise protocol on the range of motion of patients with Parkinson's disease. Timepoint: The patients' range of motion was measured first before starting the exercises and then after two months of training. Method of measurement: goniometer.</prim_outcome>
      <prim_outcome>Determining the effect of the exercise protocol on the walking speed of patients with Parkinson's disease. Timepoint: Walking speed was measured first before the start of training and then after two months of training. Method of measurement: 10 meter walking test.</prim_outcome>
      <prim_outcome>Determining the effect of an exercise protocol on the fear of falling in patients with Parkinson's disease . Timepoint: Fear of falling was measured first before the training began and then after two months of training. Method of measurement: Fear of falling questionnaire.</prim_outcome>
      <prim_outcome>Determining the effect of an exercise protocol on the quality of life of patients with Parkinson's disease. Timepoint: Quality of life was measured first before the start of the exercises and then after two months of training. Method of measurement: Specific questionnaire on quality of life for patients with Parkinson's disease.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-09-23</approval_date>
        <contact_name>Ethical Committee of Isfahan University</contact_name>
        <contact_address>Building No. 4, Vice President for Research and Technology, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
