<?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>IRCT20170114031942N10</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-21</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Water based exercise and diabetic neuropathy</public_title>
      <acronym></acronym>
      <scientific_title>Effects of water based exercise on falling risk factors in the patients with diabetic neuropathy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>46</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33684</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To allocate the participants in the research groups, a computerized list of random numbers for assigning random subjects to blocks (2, 4, 6, 8) was determined using the SPSS software by the statistical consultant. Then, the assignment of the participants is carried out by one of the research team members who are not associated with the 1: 1 assignment ratio within the training and control groups. Assignment sequences are hidden by the envelopes encoded in the order numbered, and the letter envelopes are opened only after all the initial and initial evaluations of the participants have been made.</study_design>
      <phase>3</phase>
      <hc_freetext>Diabetic neuropathy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The water treatment group participates in a 10-week water exercise program, 3 sessions a week, and 40-70 minutes per session. Each training session is guided by a trained sports trainer under the supervision of researchers. The water level with an average temperature of 30 ° C is considered constant within the boundary of the dagger appendage. The training program includes: tensile and warm-up exercises (10 minutes), endurance training (20 minutes walking and dancing), resistance training (15 minutes), balance exercises (15 minutes), and relaxation / cooling training (5 minutes). Intervention 2: Control group: Participants in this group receive only routine pre-care and no new intervention is granted to them.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ainollah Sakinepoor</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Street tagbostan, Kermanshah Preovience</address>
        <city>Kermansah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6761753164</zip>
        <telephone>+98 83 4522 6103</telephone>
        <email>asakenapoor@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Aynollah Naderi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahrood University of Technology, Shahroud, Semnan Province, Iran</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3619995161</zip>
        <telephone>+98 23 3239 2204</telephone>
        <email>ay.naderi@yahoo.com</email>
        <affiliation>Shahrood University of Technology</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 65 years old
Clinical confirmation of type 2 diabetes with peripheral neuropathy
Lower limb symptoms of peripheral neuropathy
Ability to walk home without help or with aids
Definitive electrodiagnostic evidences of peripheral neuropathy</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Severe cardiovascular diseaseHistory with evidence of plantar pressure ulcer
unstable proliferative retinopathy
End-stage renal disease and uncontrolled high blood pressure
severe structural abnormalities of the lower extremity
History or evidence of vestibular dysfunction
History with evidence of plantar pressure ulcer</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E11.40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Type 2 diabetes mellitus with diabetic neuropathy, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The water treatment group participates in a 10-week water exercise program, 3 sessions a week, and 40-70 minutes per session. Each training session is guided by a trained sports trainer under the supervision of researchers. The water level with an average temperature of 30 ° C is considered constant within the boundary of the dagger appendage. The training program includes: tensile and warm-up exercises (10 minutes), endurance training (20 minutes walking and dancing), resistance training (15 minutes), balance exercises (15 minutes), and relaxation / cooling training (5 minutes).</i_keyword>
      <i_keyword>Control group: Participants in this group receive only routine pre-care and no new intervention is granted to them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fear of falling. Timepoint: Measure the fear of falling at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the water base exercise program. Method of measurement: Fall Efficacy Scale International.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static and Dynamic Balance. Timepoint: Measure the static and dynamic balance at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the exercise program. Method of measurement: Frailty and Injuries: Cooperative Studies of Intervention Techniques–4 and Dynamic Gait Index.</sec_outcome>
      <sec_outcome>Reaction time. Timepoint: Measure the reaction time at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the water base exercise program. Method of measurement: Switch Mat.</sec_outcome>
      <sec_outcome>Fall index. Timepoint: Measure the fall index at the beginning of the study (before the intervention) and 12 and 24 weeks after the beginning of the water base exercise program. Method of measurement: Physiological Profile Assessment.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-14</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Beheshti Blvd, Kermanshah , Kermanshah Province kermansah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
