xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06013553</url>
    </required_header>
    <id_info>
      <org_study_id>MAC2023</org_study_id>
      <nct_id>NCT06013553</nct_id>
    </id_info>
    <brief_title>The Effect of Aerobic Exercise on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in Burn Patients: A Randomized Controlled Study</brief_title>
    <official_title>The Effect of Aerobic Exercise on Neutrophil-Lymphocyte Ratio, Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in Burn Patients: A Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hasan Kalyoncu University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hasan Kalyoncu University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In the study, it was planned to investigate the Effect on Neutrophil-Lymphocyte Ratio,&#xD;
        Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in burn patients by creating 2&#xD;
        different exercise groups. The aim of this study is to investigate the effect of aerobic&#xD;
        exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte&#xD;
        ratios in burn patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Burn injuries are a trauma that is seen due to causes such as flame, hot liquid, radiation,&#xD;
        chemical, cold or electricity and causes destruction in the skin and/or organic tissues due&#xD;
        to energy transfer.&#xD;
  &#xD;
        Burn injuries cause profound hypermetabolic and catabolic responses that can last for months&#xD;
        or even years. Especially in burn patients with involvement of more than 20% of the total&#xD;
        body surface area (TVSA), lipolysis, proteolysis, glycolysis, and hyperdynamic and high&#xD;
        fever, Many severe hypermetabolic responses are seen. These hypermetabolic responses seen in&#xD;
        patients lead to decrease in lean muscle mass, inflammation, deterioration of cardiovascular,&#xD;
        endocrine and glucose systems, coagulopathy, deterioration of fibrinolytic activity, decrease&#xD;
        in functional capacity, delay in wound healing, weakening of the immune system and serious&#xD;
        mortality.&#xD;
  &#xD;
        In severely burned patients, the resting metabolic rate may exceed 140% of normal.&#xD;
  &#xD;
        Various parameters are used to monitor all these systemic responses of the burn. Various&#xD;
        scores have been developed in the clinic, especially using inflammatory cells such as&#xD;
        neutrophils, monocytes, lymphocytes and platelets. In the literature, major diseases such as&#xD;
        cancer, heart diseases and burns It has been stated that a systemic inflammation occurs due&#xD;
        to trauma and calculations of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and&#xD;
        lymphocyte-monocyte ratios are prognostic indicators.&#xD;
  &#xD;
        Exercise in burn patients; It is a highly effective method with high evidence value in&#xD;
        minimizing the effects of the hypermetabolic response caused by the burn, preventing muscle&#xD;
        atrophy, increasing the pulmonary function and functional capacity, reducing the inflammatory&#xD;
        response and healing the burn.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Neutrophil lymphocyte ratio</measure>
      <time_frame>Each participant will be evaluated for 6 weeks</time_frame>
      <description>blood test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Platelet-Lymphocyte ratio</measure>
      <time_frame>Each participant will be evaluated for 6 weeks</time_frame>
      <description>blood test</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Lymphocyte Monocyte ratio</measure>
      <time_frame>Each participant will be evaluated for 6 weeks</time_frame>
      <description>blood test</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Burns</condition>
    <condition>Physiotherapy</condition>
    <condition>Aerobic Exercises</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental: Aerobic Exercises group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Aerobic exercise will be given with bicycle ergometer in addition to Standard physiotherapy (It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Group</intervention_name>
      <description>It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Aerobic Exercises group</intervention_name>
      <description>Standard physiotherapy + bicycle ergometer: In addition to the standard therapy, a bicycle ergometer for 20 minutes 5 days a week will be given.&#xD;
  Patients will turn the pedals of the bicycle while sitting on the edge of the bed.&#xD;
  In this protocol, a portable bicycle with adjustable pedal system, which can be placed on the edge of the bed, will be used.&#xD;
  &quot;Ratings of perceived exertion (RPE)&quot; will be used to determine the intensity of aerobic activity. According to the RPE, 10-12 strength exercises will be given</description>
      <arm_group_label>Experimental: Aerobic Exercises group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
          Conscious patients Enterally fed &gt;18 years old&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          With inhalation burn In addition to existing burn trauma, those with other trauma&#xD;
          (fracture, loss of limb, etc.) Organ dysfunctions or multiple organ failure History of&#xD;
          chronic diseases such as diabetes, cholesterol and blood pressure&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>MURAT A ÇINAR, DR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hasan Kalyoncu University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>MURAT A ÇINAR, DR</last_name>
      <phone>+905331639319</phone>
      <email>muratalicinar@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmet ERKILIÇ, MD</last_name>
      <phone>+90342 211 80 80</phone>
      <email>Aeres57@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hasan Kalyoncu University</name>
        <address>
          <city>Gaziantep</city>
          <zip>27000</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>MURAT A ÇINAR, DR</last_name>
        <phone>05331639319</phone>
        <email>muratalicinar@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.</citation>
      <PMID>32054846</PMID>
    </results_reference>
    <results_reference>
      <citation>Romero SA, Moralez G, Jaffery MF, Huang M, Cramer MN, Romain N, Kouda K, Haller RG, Crandall CG. Progressive exercise training improves maximal aerobic capacity in individuals with well-healed burn injuries. Am J Physiol Regul Integr Comp Physiol. 2019 Oct 1;317(4):R563-R570. doi: 10.1152/ajpregu.00201.2019. Epub 2019 Aug 21.</citation>
      <PMID>31433672</PMID>
    </results_reference>
    <results_reference>
      <citation>Nielson CB, Duethman NC, Howard JM, Moncure M, Wood JG. Burns: Pathophysiology of Systemic Complications and Current Management. J Burn Care Res. 2017 Jan/Feb;38(1):e469-e481. doi: 10.1097/BCR.0000000000000355.</citation>
      <PMID>27183443</PMID>
    </results_reference>
    <results_reference>
      <citation>Cinar MA, Bayramlar K, Erkilic A, Gunes A, Yakut Y. The effects of early physiotherapy on biochemical parameters in major burn patients: A burn center's experience. Ulus Travma Acil Cerrahi Derg. 2019 Sep;25(5):461-466. doi: 10.5505/tjtes.2018.05950.</citation>
      <PMID>31475319</PMID>
    </results_reference>
    <results_reference>
      <citation>Flores O, Tyack Z, Stockton K, Paratz JD. The use of exercise in burns rehabilitation: A worldwide survey of practice. Burns. 2020 Mar;46(2):322-332. doi: 10.1016/j.burns.2019.02.016. Epub 2019 Dec 18.</citation>
      <PMID>31864784</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hasan Kalyoncu University</investigator_affiliation>
      <investigator_full_name>Murat Ali ÇINAR</investigator_full_name>
      <investigator_title>assistive professor</investigator_title>
    </responsible_party>
    <keyword>burns,</keyword>
    <keyword>neutrophil lymphocyte ratio</keyword>
    <keyword>Platelet-Lymphocyte ratio</keyword>
    <keyword>Lymphocyte Monocyte ratio</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Burns</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06013553
  org study id: MAC2023
  nct id: NCT06013553
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In the study, it was planned to investigate the Effect on Neutrophil-Lymphocyte Ratio,
        Platelet-Lymphocyte Ratio and Lymphocyte-Monocyte Ratio in burn patients by creating 2
        different exercise groups. The aim of this study is to investigate the effect of aerobic
        exercise on neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and lymphocyte-monocyte
        ratios in burn patients.
  Burn injuries are a trauma that is seen due to causes such as flame, hot liquid, radiation,
        chemical, cold or electricity and causes destruction in the skin and/or organic tissues due
        to energy transfer.
  
        Burn injuries cause profound hypermetabolic and catabolic responses that can last for months
        or even years. Especially in burn patients with involvement of more than 20% of the total
        body surface area (TVSA), lipolysis, proteolysis, glycolysis, and hyperdynamic and high
        fever, Many severe hypermetabolic responses are seen. These hypermetabolic responses seen in
        patients lead to decrease in lean muscle mass, inflammation, deterioration of cardiovascular,
        endocrine and glucose systems, coagulopathy, deterioration of fibrinolytic activity, decrease
        in functional capacity, delay in wound healing, weakening of the immune system and serious
        mortality.
  
        In severely burned patients, the resting metabolic rate may exceed 140% of normal.
  
        Various parameters are used to monitor all these systemic responses of the burn. Various
        scores have been developed in the clinic, especially using inflammatory cells such as
        neutrophils, monocytes, lymphocytes and platelets. In the literature, major diseases such as
        cancer, heart diseases and burns It has been stated that a systemic inflammation occurs due
        to trauma and calculations of neutrophil-lymphocyte ratio, platelet-lymphocyte ratio and
        lymphocyte-monocyte ratios are prognostic indicators.
  
        Exercise in burn patients; It is a highly effective method with high evidence value in
        minimizing the effects of the hypermetabolic response caused by the burn, preventing muscle
        atrophy, increasing the pulmonary function and functional capacity, reducing the inflammatory
        response and healing the burn.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Neutrophil lymphocyte ratio
  time frame: Each participant will be evaluated for 6 weeks
  description: blood test
  measure: Platelet-Lymphocyte ratio
  time frame: Each participant will be evaluated for 6 weeks
  description: blood test
  measure: Lymphocyte Monocyte ratio
  time frame: Each participant will be evaluated for 6 weeks
  description: blood test
  arm group label: control group
  arm group type: Active Comparator
  description: Standard physiotherapy (1st Group): It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
  arm group label: Experimental: Aerobic Exercises group
  arm group type: Experimental
  description: Aerobic exercise will be given with bicycle ergometer in addition to Standard physiotherapy (It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises)
  intervention type: Other
  intervention name: Control Group
  description: It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
  arm group label: control group
  intervention type: Other
  intervention name: Aerobic Exercises group
  description: Standard physiotherapy + bicycle ergometer: In addition to the standard therapy, a bicycle ergometer for 20 minutes 5 days a week will be given.
  Patients will turn the pedals of the bicycle while sitting on the edge of the bed.
  In this protocol, a portable bicycle with adjustable pedal system, which can be placed on the edge of the bed, will be used.
  "Ratings of perceived exertion (RPE)" will be used to determine the intensity of aerobic activity. According to the RPE, 10-12 strength exercises will be given
  arm group label: Experimental: Aerobic Exercises group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: MURAT A ÇINAR, DR
  role: Principal Investigator
  affiliation: Hasan Kalyoncu University
  last name: MURAT A ÇINAR, DR
  phone: +905331639319
  email: muratalicinar@gmail.com
  last name: Ahmet ERKILIÇ, MD
  phone: +90342 211 80 80
  email: Aeres57@yahoo.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  citation: Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5.
  PMID: 32054846
  citation: Romero SA, Moralez G, Jaffery MF, Huang M, Cramer MN, Romain N, Kouda K, Haller RG, Crandall CG. Progressive exercise training improves maximal aerobic capacity in individuals with well-healed burn injuries. Am J Physiol Regul Integr Comp Physiol. 2019 Oct 1;317(4):R563-R570. doi: 10.1152/ajpregu.00201.2019. Epub 2019 Aug 21.
  PMID: 31433672
  citation: Nielson CB, Duethman NC, Howard JM, Moncure M, Wood JG. Burns: Pathophysiology of Systemic Complications and Current Management. J Burn Care Res. 2017 Jan/Feb;38(1):e469-e481. doi: 10.1097/BCR.0000000000000355.
  PMID: 27183443
  citation: Cinar MA, Bayramlar K, Erkilic A, Gunes A, Yakut Y. The effects of early physiotherapy on biochemical parameters in major burn patients: A burn center's experience. Ulus Travma Acil Cerrahi Derg. 2019 Sep;25(5):461-466. doi: 10.5505/tjtes.2018.05950.
  PMID: 31475319
  citation: Flores O, Tyack Z, Stockton K, Paratz JD. The use of exercise in burns rehabilitation: A worldwide survey of practice. Burns. 2020 Mar;46(2):322-332. doi: 10.1016/j.burns.2019.02.016. Epub 2019 Dec 18.
  PMID: 31864784
  responsible party type: Principal Investigator
  investigator affiliation: Hasan Kalyoncu University
  investigator full name: Murat Ali ÇINAR
  investigator title: assistive professor
  mesh term: Burns
  sharing ipd: No