<?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>IRCT20170614034529N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-19</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effects of Aerobic Exercise and Resistance on Changes in the Risk Factors of Cardiovascular Diseases in Elderly People with Hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Aerobic Exercise and Resistance on Changes in the Risk Factors of Cardiovascular Diseases in Elderly People with Hypertension in Kermanshah Elderly Houses</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-05-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>57</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/26364</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: According to the number of samples examined, from the table of random numbers, single-digit numbers between 0 and 9 will be selected.
For studies with two groups, the numbers 0-9 are divided into two equal blocks that the probability of allocating the individual to each block is 0.5. Block 0-4 can be used for the first group and block 5-9 for the second group. Based on the numbers selected from the table of random numbers and the determination of the blocks, it is clear in which group each person entering the study will be placed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Risk factors for cardiovascular disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: For the aerobic exercise group, a regular exercise program in the form of sub-aerobic aerobic exercise for 12 weeks and 3 sessions per week with a duration of 45 minutes per session will be provided. Exercise will be present and the checklist designed by the researcher will be evaluated with the correct amount of performance. For each group, an explanatory training session will be held in one of the nursing home halls. In all three groups, the risk factors will be measured and recorded first by performing a pre-test (blood test).And at the end of the project, a post-test is done. Intervention 2: Intervention group2: In the Resistance Sports Group, using a physiotherapy exercise, they are taught how to perform movements that stand one meter away from the wall and connect the Traband to the wall. Kneel on each knee for 4 minutes. And in 12 weeks and 3 sessions per week with a time of 16 minutes in each session (according to the physiotherapist) will be presented.Exercise will be present and the checklist designed by the researcher will be evaluated with the correct amount of performance. For each group, an explanatory training session will be held in one of the nursing home halls. In all three groups, the risk factors will be measured and recorded first by performing a pre-test (blood test).And at the end of the project, a post-test is done. Intervention 3: Control group: There is no intervention for the control group.</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 There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Samira Fattahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3828 2088</telephone>
        <email>s_fatahi20@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samira Fattahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolatabad Blvd</address>
        <city>kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6719851351</zip>
        <telephone>+98 83 3828 2088</telephone>
        <email>s_fatahi20@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Lack of chronic diseases
No surgery
Not having history of acute and chronic kidney failure, Cushing's disease and aortic quorum phaeochromocytoma
Regular inactivity
Sports inactivity in the last month
No smoking
Non-use of pharmaceutical supplements
No addiction
Having ages 90-65 years
Catching blood pressure
Having mental health
Awareness and hearing and speaking to an extent that does not prevent research</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>90 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The lack of cooperation or the death of the elderly
Leave the sanatorium for any reason
Blood pressure greater than 136 | 196 mm Hg
Hospitalization in the health sector
Failure to implement the sport protocol
Unstable angina
Cardiac insufficiency not compensated
Myocardial infarction over the past 4 weeks
Ventricular arrhythmias</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: For the aerobic exercise group, a regular exercise program in the form of sub-aerobic aerobic exercise for 12 weeks and 3 sessions per week with a duration of 45 minutes per session will be provided. Exercise will be present and the checklist designed by the researcher will be evaluated with the correct amount of performance. For each group, an explanatory training session will be held in one of the nursing home halls. In all three groups, the risk factors will be measured and recorded first by performing a pre-test (blood test).And at the end of the project, a post-test is done.</i_keyword>
      <i_keyword>Intervention group2: In the Resistance Sports Group, using a physiotherapy exercise, they are taught how to perform movements that stand one meter away from the wall and connect the Traband to the wall. Kneel on each knee for 4 minutes. And in 12 weeks and 3 sessions per week with a time of 16 minutes in each session (according to the physiotherapist) will be presented.Exercise will be present and the checklist designed by the researcher will be evaluated with the correct amount of performance. For each group, an explanatory training session will be held in one of the nursing home halls. In all three groups, the risk factors will be measured and recorded first by performing a pre-test (blood test).And at the end of the project, a post-test is done.</i_keyword>
      <i_keyword>Control group: There is no intervention for the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cholesterol, triglycerides, LDL, HDL, blood sugar. Timepoint: Before the intervention, after the intervention. Method of measurement: blood test.</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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-12</approval_date>
        <contact_name>National Ethics Committee for Biomedical Research</contact_name>
        <contact_address>Thirteenth floor,.Block A,.Irn Street - Cenan-Ira Headquarters of the Ministry of Health and Medical Education,.Between South Felamak and Zarafshan Kermanshah Kermanshah Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
