<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/NCT03776734</url>
  </required_header>
  <id_info>
    <org_study_id>ETK00-2017-0296</org_study_id>
    <nct_id>NCT03776734</nct_id>
  </id_info>
  <brief_title>Effects of Cold Application on Exercise Performance</brief_title>
  <official_title>Effects of Different Durations of Cold Application on Respiratory Function, Exercise Capacity and Muscle Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Mediterranean University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Mediterranean University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      It is of utmost importance to determine the individual upper limits in the recommended&#xD;
      exercises for increasing the level of physical activity and for developing the cardiovascular&#xD;
      system. Cardiovascular exercise tests are used in determining the exercise capacity and&#xD;
      performance. Cardiovascular exercise tests allow maximal and submaximal loadings to determine&#xD;
      the person's body temperature, oxygen consumption, fatigue, interpretation of cardiac&#xD;
      responses, and exercise capacity.&#xD;
&#xD;
      Thermal equilibrium is achieved by the activation or inhibition of autonomic and behavioral&#xD;
      thermocouples in order to generate, dissipate or protect heat. These thermocouples act&#xD;
      together and allow precise control of body temperature, which is arranged in a narrow range.&#xD;
&#xD;
      Under certain conditions, such as body temperature, systemic inflammation, extreme&#xD;
      environmental conditions, and exercise performance, it falls outside this narrow range.&#xD;
      Metabolic heat production is 15 to 20 times greater than resting during exercise. In exercise&#xD;
      performed under hot ambient conditions, the rate of heat production will exceed the rate of&#xD;
      heat loss and cause it to rise rapidly before reaching a plateau. The increase due to the&#xD;
      exhalation of body heat initiates two autonomous thermodynamics for heat dissipation:&#xD;
      sweating and cutaneous vasodilatation. Although both mechanisms help prevent exaggerated&#xD;
      increase in body temperature, they cause stress for the cardiovascular system.&#xD;
&#xD;
      Exercise performance and level of physical activity are influenced by individual&#xD;
      characteristics such as personality adjustment and mediocre adjustment. Adaptation is defined&#xD;
      as adaptation under natural conditions. Robinson showed that the individual salt losses are&#xD;
      higher in individuals who exercise in a hot environment and cannot adapt to the temperature,&#xD;
      a decrease in both urine and sweat salt contents with temperature compliance. One research&#xD;
      has shown that exercise performance is influenced by heat-induced muscle cramps and&#xD;
      cardiovascular function disorders due to this significant increase in salt loss. An increase&#xD;
      in body temperature caused by exercise can have a negative impact on exercise performance and&#xD;
      may lead to the development of conditions associated with increased body temperature.&#xD;
&#xD;
      Although many studies in literature have shown positive effects of performance of&#xD;
      pre-exercise cold exercise on performance, there is no consensus on the use of cold&#xD;
      applications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In our study, changes that may arise from individual differences will be tried to be&#xD;
      controlled using repetitive measurements in the same individuals. Evaluation results will be&#xD;
      recorded without any cold application in order to determine the circumstances prior to the&#xD;
      application. In the following weeks, doses to both Quadriceps muscles will be recorded&#xD;
      immediately after cold application of 5 minutes, 10 minutes and 20 minutes. Each of the&#xD;
      applications will be held on the same day of the week and at the same time in 4 consecutive&#xD;
      weeks. Nutritional and fluid trains (such as stimulant substances, amount of coffee tea),&#xD;
      ambient conditions (temperature and humidity) that may affect individual performance will be&#xD;
      recorded. Keeping room conditions under control will benefit from air conditioning.&#xD;
      Individuals will be informed about the equipment and test protocol to be used in the tests. A&#xD;
      sufficient number of trials will be done before the test so that the participants are&#xD;
      familiar with the equipment and test protocol. All assessments will be performed by the same&#xD;
      physiotherapist.&#xD;
&#xD;
      Participant Evaluation:&#xD;
&#xD;
        -  Body composition will be assessed by height, weight, body fat percentage and skin&#xD;
           thickness measurements. (TANİTA and Skinfold measurements)&#xD;
&#xD;
        -  Bruce protocol with the aim of determining the exercise capacity (Bruce protocol&#xD;
           installed on the treadmill), fatigue (lactate measurement device), heart rate (Polar&#xD;
           wireless heart rate index), blood pressure (manual sphygmomanometer), saturated oxygen&#xD;
           level (pulse oximetry) and oxygen consumption (metabolic gas analyzer) measurements.&#xD;
&#xD;
        -  Respiratory Function Test (Spirometer, FEV1, FVC, FEV1 / FVC, FEF (25-75), PEF, MVV)&#xD;
           should be performed for evaluation of respiratory functions.&#xD;
&#xD;
        -  Respiratory muscle strength will be assessed by in-mouth pressure measurements (MIP-MEP&#xD;
           device) during inhalation and exhalation.&#xD;
&#xD;
        -  The application area will be assessed by dual laser infrared non-contact superficial&#xD;
           temperature measurement thermometer and general body temperature infrared in-ear&#xD;
           thermometer.&#xD;
&#xD;
        -  Assessment of muscle strength and muscular endurance will be assessed with an isokinetic&#xD;
           dynamometer.&#xD;
&#xD;
      Application Program:&#xD;
&#xD;
      Keeping room conditions, temperature and humidity under control will benefit from air&#xD;
      conditioning. Temperature and humidity percentage indicator will be used when room conditions&#xD;
      are monitored. Cooled ice packs of gel will be used to cool the quadriceps muscles. The&#xD;
      amount of heat of the gel packets, before and after application of the application area, will&#xD;
      be recorded by measuring with an infrared non-contact thermometer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 30, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Exercise capacity</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Oxygen consumption on maximal exercise test (Bruce Protocol) will be assessed with mobile metabolic analyzer system as expended oxygen level per kilogram in one minute (ml/kg/min.) will be measured after cold application.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle strength</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Concentric quadriceps muscle torque values will be measured with isokinetic dynamometer as Newton-meter with speed of 60 and 240 degrees in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle endurance</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Quadriceps muscle endurance values will be measured with isokinetic dynamometer as endurance percentage(%) with speed of 240 degrees in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Forced expiratory volume in one second as liter (FEV1) will be measured with spirometry test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced vital capacity</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Forced vital capacity as liter (FVC) will be measured with spirometry test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Peak expiratory flow as liter in one second (PEF) will be measured with spirometry test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory flow</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Forced expiratory flow as liter (FEF25-75%) will be measured with spirometry test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal voluntary ventilation</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Maximal voluntary ventilation as liter in one minute (MVV) will be measured with spirometry test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal inspiration pressure</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Maximal inspiration pressure (MIP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal expiration pressure</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Maximal expiration pressure (MEP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.</time_frame>
    <description>Lactate level will be measured before and after maximal test.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Cryotherapy Effect</condition>
  <arm_group>
    <arm_group_label>cryotherapy application</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>effect of cold application</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cryotherapy application</intervention_name>
    <description>Effects of 5-10- 20 minutes cold application on quadriceps muscle</description>
    <arm_group_label>cryotherapy application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, healthy individuals between the ages of 18-25&#xD;
&#xD;
          -  individuals without peripheral circulatory disturbances&#xD;
&#xD;
          -  Individuals without chronic disease&#xD;
&#xD;
          -  Individuals without orthopedic, neurological, cardiopulmonary disturbances that may&#xD;
             prevent evaluation and measurement&#xD;
&#xD;
          -  individuals who have not exercised regularly in the past six months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with sensory loss&#xD;
&#xD;
          -  Individuals with cold hypersensitivity&#xD;
&#xD;
          -  Drug users who may influence performance&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>İLKER YATAR, MSc. PT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Mediterranean University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>İLKER YATAR, MSc. PT</last_name>
    <phone>00903926303067</phone>
    <email>ilker.yatar@emu.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eastern Mediterranean University</name>
      <address>
        <city>Famagusta</city>
        <country>Cyprus</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>İLKER YATAR, MSc. PT</last_name>
      <phone>+903926303067</phone>
      <email>ilker.yatar@emu.edu.tr</email>
    </contact>
    <investigator>
      <last_name>ilker yatar, MSc. PT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Cyprus</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eastern Mediterranean University</investigator_affiliation>
    <investigator_full_name>İlker Yatar</investigator_full_name>
    <investigator_title>Senior İnstructor</investigator_title>
  </responsible_party>
  <keyword>precooling</keyword>
  <keyword>exercise</keyword>
  <keyword>pulmonary function</keyword>
  <keyword>isokinetic</keyword>
  <keyword>lactate</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03776734
org study id: ETK00-2017-0296
nct id: NCT03776734
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It is of utmost importance to determine the individual upper limits in the recommended
      exercises for increasing the level of physical activity and for developing the cardiovascular
      system. Cardiovascular exercise tests are used in determining the exercise capacity and
      performance. Cardiovascular exercise tests allow maximal and submaximal loadings to determine
      the person's body temperature, oxygen consumption, fatigue, interpretation of cardiac
      responses, and exercise capacity.

      Thermal equilibrium is achieved by the activation or inhibition of autonomic and behavioral
      thermocouples in order to generate, dissipate or protect heat. These thermocouples act
      together and allow precise control of body temperature, which is arranged in a narrow range.

      Under certain conditions, such as body temperature, systemic inflammation, extreme
      environmental conditions, and exercise performance, it falls outside this narrow range.
      Metabolic heat production is 15 to 20 times greater than resting during exercise. In exercise
      performed under hot ambient conditions, the rate of heat production will exceed the rate of
      heat loss and cause it to rise rapidly before reaching a plateau. The increase due to the
      exhalation of body heat initiates two autonomous thermodynamics for heat dissipation:
      sweating and cutaneous vasodilatation. Although both mechanisms help prevent exaggerated
      increase in body temperature, they cause stress for the cardiovascular system.

      Exercise performance and level of physical activity are influenced by individual
      characteristics such as personality adjustment and mediocre adjustment. Adaptation is defined
      as adaptation under natural conditions. Robinson showed that the individual salt losses are
      higher in individuals who exercise in a hot environment and cannot adapt to the temperature,
      a decrease in both urine and sweat salt contents with temperature compliance. One research
      has shown that exercise performance is influenced by heat-induced muscle cramps and
      cardiovascular function disorders due to this significant increase in salt loss. An increase
      in body temperature caused by exercise can have a negative impact on exercise performance and
      may lead to the development of conditions associated with increased body temperature.

      Although many studies in literature have shown positive effects of performance of
      pre-exercise cold exercise on performance, there is no consensus on the use of cold
      applications.
In our study, changes that may arise from individual differences will be tried to be
      controlled using repetitive measurements in the same individuals. Evaluation results will be
      recorded without any cold application in order to determine the circumstances prior to the
      application. In the following weeks, doses to both Quadriceps muscles will be recorded
      immediately after cold application of 5 minutes, 10 minutes and 20 minutes. Each of the
      applications will be held on the same day of the week and at the same time in 4 consecutive
      weeks. Nutritional and fluid trains (such as stimulant substances, amount of coffee tea),
      ambient conditions (temperature and humidity) that may affect individual performance will be
      recorded. Keeping room conditions under control will benefit from air conditioning.
      Individuals will be informed about the equipment and test protocol to be used in the tests. A
      sufficient number of trials will be done before the test so that the participants are
      familiar with the equipment and test protocol. All assessments will be performed by the same
      physiotherapist.

      Participant Evaluation:

        -  Body composition will be assessed by height, weight, body fat percentage and skin
           thickness measurements. (TANİTA and Skinfold measurements)

        -  Bruce protocol with the aim of determining the exercise capacity (Bruce protocol
           installed on the treadmill), fatigue (lactate measurement device), heart rate (Polar
           wireless heart rate index), blood pressure (manual sphygmomanometer), saturated oxygen
           level (pulse oximetry) and oxygen consumption (metabolic gas analyzer) measurements.

        -  Respiratory Function Test (Spirometer, FEV1, FVC, FEV1 / FVC, FEF (25-75), PEF, MVV)
           should be performed for evaluation of respiratory functions.

        -  Respiratory muscle strength will be assessed by in-mouth pressure measurements (MIP-MEP
           device) during inhalation and exhalation.

        -  The application area will be assessed by dual laser infrared non-contact superficial
           temperature measurement thermometer and general body temperature infrared in-ear
           thermometer.

        -  Assessment of muscle strength and muscular endurance will be assessed with an isokinetic
           dynamometer.

      Application Program:

      Keeping room conditions, temperature and humidity under control will benefit from air
      conditioning. Temperature and humidity percentage indicator will be used when room conditions
      are monitored. Cooled ice packs of gel will be used to cool the quadriceps muscles. The
      amount of heat of the gel packets, before and after application of the application area, will
      be recorded by measuring with an infrared non-contact thermometer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Exercise capacity
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Oxygen consumption on maximal exercise test (Bruce Protocol) will be assessed with mobile metabolic analyzer system as expended oxygen level per kilogram in one minute (ml/kg/min.) will be measured after cold application.
measure: Muscle strength
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Concentric quadriceps muscle torque values will be measured with isokinetic dynamometer as Newton-meter with speed of 60 and 240 degrees in seconds
measure: Muscle endurance
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Quadriceps muscle endurance values will be measured with isokinetic dynamometer as endurance percentage(%) with speed of 240 degrees in seconds
measure: Forced expiratory volume
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Forced expiratory volume in one second as liter (FEV1) will be measured with spirometry test
measure: Forced vital capacity
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Forced vital capacity as liter (FVC) will be measured with spirometry test
measure: Peak expiratory flow
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Peak expiratory flow as liter in one second (PEF) will be measured with spirometry test
measure: Forced expiratory flow
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Forced expiratory flow as liter (FEF25-75%) will be measured with spirometry test
measure: Maximal voluntary ventilation
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Maximal voluntary ventilation as liter in one minute (MVV) will be measured with spirometry test
measure: Maximal inspiration pressure
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Maximal inspiration pressure (MIP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.
measure: Maximal expiration pressure
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Maximal expiration pressure (MEP) represented by centimeters of water pressure (cmH2O) and measured with a manometer.
measure: Fatigue
time frame: Before and after of each cold application. Each application will be applied same day and time of the week. All the application and measurement will take total 4 weeks for each subject.
description: Lactate level will be measured before and after maximal test.
arm group label: cryotherapy application
arm group type: Experimental
description: effect of cold application
intervention type: Other
intervention name: Cryotherapy application
description: Effects of 5-10- 20 minutes cold application on quadriceps muscle
arm group label: cryotherapy application
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: İLKER YATAR, MSc. PT
role: Principal Investigator
affiliation: Eastern Mediterranean University
last name: İLKER YATAR, MSc. PT
phone: 00903926303067
email: ilker.yatar@emu.edu.tr
facility: 
status: Recruiting
contact: 
investigator: 
country: Cyprus
responsible party type: Principal Investigator
investigator affiliation: Eastern Mediterranean University
investigator full name: İlker Yatar
investigator title: Senior İnstructor
sharing ipd: Undecided