<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/NCT04420819</url>
  </required_header>
  <id_info>
    <org_study_id>FCT/UNESP</org_study_id>
    <nct_id>NCT04420819</nct_id>
  </id_info>
  <brief_title>Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise</brief_title>
  <official_title>Effects of Ischemic Preconditioning on Muscle Damage Induced by Excentric Exercise: Randomized Clinical Trial Placebo Controlled</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paulista University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paulista 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>
      Introduction: eccentric exercise (EE) has been widely used in rehabilitation and in improving&#xD;
      physical fitness due to its mechanical advantage and less metabolic demand, however, EE can&#xD;
      induce muscle damage providing structural changes and reduced muscle function, therefore, it&#xD;
      is necessary to look for alternatives to reduce this damage caused by stress. Thus, ischemic&#xD;
      preconditioning (PCI) can be seen as an aid in reducing the damage caused by EE, as it can&#xD;
      attenuate the ischemia-reperfusion injury, and can be used to accelerate the post-exercise&#xD;
      recovery process. Objectives: to compare the effects of PCI, using different occlusion&#xD;
      pressures, on acute and late responses to perceptual outcomes and muscle injury markers, in&#xD;
      addition to checking whether the technique causes deleterious effects on performance in&#xD;
      post-exercise recovery. Methods: a randomized placebo controlled clinical trial will be&#xD;
      conducted with 80 healthy men aged 18 to 35 years who will be randomly divided into four&#xD;
      groups: PCI using total occlusion pressure (POT), PCI with 40% more than POT, placebo (10&#xD;
      mmHg) and control. The PCI protocol will consist of four cycles of ischemia and reperfusion&#xD;
      of five minutes each. All groups will perform an EE protocol, initial assessments,&#xD;
      immediately after the end of the EE, 24, 48, 72 and 96 hours after exercise, with the maximum&#xD;
      isometric voluntary contraction (CVIM) assessed by the isokinetic dynamometer, vectors of&#xD;
      cell integrity by by means of electrical bioimpedance (BIA), creatine kinase (CK), blood&#xD;
      lactate, pain on the visual analog scale (VAS), pain threshold by the pressure algometer, and&#xD;
      tone, muscle rigidity and elasticity by myotonometry. The descriptive statistical method and&#xD;
      analysis of variance will be used for the repeated measures model. The level of significance&#xD;
      will be p &lt;0.05.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</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>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Muscle damage</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood lactate concentration</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Muscle strength in isokinetic</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Maximal voluntary isometric contraction (MVIC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscle pain</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Assessed using a visual analog scale that ranges from 0 to 10 points, the higher the score, the worse the result.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain threshold</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Assessed using pressure algometer equipment, and the pain threshold will be classified according to the cut-off point of 2.55kgf. Participants will be classified as &quot;sensitive to pain&quot; if they have values below 2.55kgf.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistance through Bioimpedance analysis (BIA)</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Evaluation of tissue resistance, the higher the value, the worse the result</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reactance through Bioimpedance analysis (BIA)</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Evaluation of tissue reactance, the higher the value, the better the cell integrity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase angle through Bioimpedance analysis (BIA)</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Assessment of the phase angle, the higher the value, the better the condition of the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tone muscular through Myotonometry used the MyotonPRO equipment</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Natural Oscillation Frequency [Hz], characterizing Tone of the quadriceps femoris muscle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stiffness through Myotonometry used the MyotonPRO equipment</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Dynamic Stiffness [N/m] of the quadriceps femoris muscle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elasticity through Myotonometry used the MyotonPRO equipment</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the quadriceps femoris muscle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perception of recovery</measure>
    <time_frame>Change from baseline at 96 hours after exercise</time_frame>
    <description>Perception of recovery was obtained using a 10-point Likert Scale, with a rating of 1 indicating the feeling &quot;not recovered&quot; and a rating of 10 the feeling &quot;fully recovered&quot;</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>IPC-LOP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group will carry out the baseline assessments, perform the ischemic preconditioning using exactly the limb occlusion pressure , then perform post-IPC assessments and start the excentric exercise, and the post-exercise assessments will take place immediately after the end of the EE and will be repeated in 24h, 48h, 72h and 96h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPC-40%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group will carry out baseline assessments, perform IPC using 40% more occlusion than LOP, then perform assessments after IPC protocol and start EE, and post exercise assessments will take place immediately after the end of EE and will be repeated in 24h, 48h, 72h and 96h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPC-10mmHg:</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>this group will perform baseline assessments, perform occlusion-perfusion intervention with 10 mmHg restriction characterizing the placebo, then perform post-IPC assessments and initiate EE, and post-exercise assessments will take place immediately after completion of EE and if will repeat in 24h, 48h, 72h and 96h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTR</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>this group will carry out the baseline assessments, immediately after starting the EE, and the post-exercise assessments will happen immediately after the end of the EE and will be repeated in 24h, 48h, 72h and 96h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ischemic Preconditioning</intervention_name>
    <description>The IPC is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff</description>
    <arm_group_label>IPC-10mmHg:</arm_group_label>
    <arm_group_label>IPC-40%</arm_group_label>
    <arm_group_label>IPC-LOP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  not having any health condition that contraindicates or prevents EE;&#xD;
&#xD;
          -  not having diagnosed diabetes and high blood pressure;&#xD;
&#xD;
          -  not having inflammatory, psychiatric, cardiovascular and / or respiratory rheumatic&#xD;
             disease;&#xD;
&#xD;
          -  not being an alcoholic, using drugs and / or a smoker;&#xD;
&#xD;
          -  without a history of knee surgery (for example, meniscal repair and ligament&#xD;
             reconstruction) or recent musculoskeletal injury to the lower limbs that may impair&#xD;
             performance during tests or interventions (for example, muscle injury, tendinopathy,&#xD;
             patellofemoral pain in the lower limbs and / or back pain in the last six months);&#xD;
&#xD;
          -  without involvement in any type of training program during the study period;&#xD;
&#xD;
          -  not being engaged in the lower limb strength training program during the three months&#xD;
             prior to participating in the study;&#xD;
&#xD;
          -  not using ergogenic supplements to improve physical performance and / or muscle mass&#xD;
             and / or vasoactive drugs;&#xD;
&#xD;
          -  not having one or more risk factors predisposing to thromboembolism.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  present a health problem that does not allow continuity,&#xD;
&#xD;
          -  use medication, electrotherapy or other therapeutic means that may interfere with any&#xD;
             result;&#xD;
&#xD;
          -  perform unusual or strenuous physical activities during the evaluation period;&#xD;
&#xD;
          -  want to leave the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Franciele Marques Vanderlei</name>
      <address>
        <city>Presidente Prudente</city>
        <state>SP</state>
        <zip>55</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Paulista University</investigator_affiliation>
    <investigator_full_name>Franciele Marques Vanderle</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ischemic Preconditioning</keyword>
  <keyword>Exercise</keyword>
  <keyword>Musculoskeletal Pain</keyword>
  <keyword>Creatine Kinase</keyword>
  <keyword>Muscle Fatigue</keyword>
  <keyword>Stress, Physiological</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ischemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04420819
org study id: FCT/UNESP
nct id: NCT04420819
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: eccentric exercise (EE) has been widely used in rehabilitation and in improving
      physical fitness due to its mechanical advantage and less metabolic demand, however, EE can
      induce muscle damage providing structural changes and reduced muscle function, therefore, it
      is necessary to look for alternatives to reduce this damage caused by stress. Thus, ischemic
      preconditioning (PCI) can be seen as an aid in reducing the damage caused by EE, as it can
      attenuate the ischemia-reperfusion injury, and can be used to accelerate the post-exercise
      recovery process. Objectives: to compare the effects of PCI, using different occlusion
      pressures, on acute and late responses to perceptual outcomes and muscle injury markers, in
      addition to checking whether the technique causes deleterious effects on performance in
      post-exercise recovery. Methods: a randomized placebo controlled clinical trial will be
      conducted with 80 healthy men aged 18 to 35 years who will be randomly divided into four
      groups: PCI using total occlusion pressure (POT), PCI with 40% more than POT, placebo (10
      mmHg) and control. The PCI protocol will consist of four cycles of ischemia and reperfusion
      of five minutes each. All groups will perform an EE protocol, initial assessments,
      immediately after the end of the EE, 24, 48, 72 and 96 hours after exercise, with the maximum
      isometric voluntary contraction (CVIM) assessed by the isokinetic dynamometer, vectors of
      cell integrity by by means of electrical bioimpedance (BIA), creatine kinase (CK), blood
      lactate, pain on the visual analog scale (VAS), pain threshold by the pressure algometer, and
      tone, muscle rigidity and elasticity by myotonometry. The descriptive statistical method and
      analysis of variance will be used for the repeated measures model. The level of significance
      will be p <0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Muscle damage
time frame: Change from baseline at 96 hours after exercise
description: Plasma CK concentration will be obtained by means of 32 μL of capillary blood collected from the digital pulp.
measure: Blood lactate concentration
time frame: Change from baseline at 96 hours after exercise
description: Blood lactate concentration of the participant will be collected 25 ml of blood with an ear lobe capillary
measure: Muscle strength in isokinetic
time frame: Change from baseline at 96 hours after exercise
description: Maximal voluntary isometric contraction (MVIC)
measure: Muscle pain
time frame: Change from baseline at 96 hours after exercise
description: Assessed using a visual analog scale that ranges from 0 to 10 points, the higher the score, the worse the result.
measure: Pain threshold
time frame: Change from baseline at 96 hours after exercise
description: Assessed using pressure algometer equipment, and the pain threshold will be classified according to the cut-off point of 2.55kgf. Participants will be classified as "sensitive to pain" if they have values below 2.55kgf.
measure: Resistance through Bioimpedance analysis (BIA)
time frame: Change from baseline at 96 hours after exercise
description: Evaluation of tissue resistance, the higher the value, the worse the result
measure: Reactance through Bioimpedance analysis (BIA)
time frame: Change from baseline at 96 hours after exercise
description: Evaluation of tissue reactance, the higher the value, the better the cell integrity
measure: Phase angle through Bioimpedance analysis (BIA)
time frame: Change from baseline at 96 hours after exercise
description: Assessment of the phase angle, the higher the value, the better the condition of the participant
measure: Tone muscular through Myotonometry used the MyotonPRO equipment
time frame: Change from baseline at 96 hours after exercise
description: Natural Oscillation Frequency [Hz], characterizing Tone of the quadriceps femoris muscle
measure: Stiffness through Myotonometry used the MyotonPRO equipment
time frame: Change from baseline at 96 hours after exercise
description: Dynamic Stiffness [N/m] of the quadriceps femoris muscle
measure: Elasticity through Myotonometry used the MyotonPRO equipment
time frame: Change from baseline at 96 hours after exercise
description: Mechanical Stress Relaxation Time [ms] featuring muscle elasticity of the quadriceps femoris muscle
measure: Perception of recovery
time frame: Change from baseline at 96 hours after exercise
description: Perception of recovery was obtained using a 10-point Likert Scale, with a rating of 1 indicating the feeling "not recovered" and a rating of 10 the feeling "fully recovered"
arm group label: IPC-LOP
arm group type: Experimental
description: this group will carry out the baseline assessments, perform the ischemic preconditioning using exactly the limb occlusion pressure , then perform post-IPC assessments and start the excentric exercise, and the post-exercise assessments will take place immediately after the end of the EE and will be repeated in 24h, 48h, 72h and 96h.
arm group label: IPC-40%
arm group type: Experimental
description: this group will carry out baseline assessments, perform IPC using 40% more occlusion than LOP, then perform assessments after IPC protocol and start EE, and post exercise assessments will take place immediately after the end of EE and will be repeated in 24h, 48h, 72h and 96h.
arm group label: IPC-10mmHg:
arm group type: Placebo Comparator
description: this group will perform baseline assessments, perform occlusion-perfusion intervention with 10 mmHg restriction characterizing the placebo, then perform post-IPC assessments and initiate EE, and post-exercise assessments will take place immediately after completion of EE and if will repeat in 24h, 48h, 72h and 96h.
arm group label: CONTR
arm group type: No Intervention
description: this group will carry out the baseline assessments, immediately after starting the EE, and the post-exercise assessments will happen immediately after the end of the EE and will be repeated in 24h, 48h, 72h and 96h.
intervention type: Device
intervention name: Ischemic Preconditioning
description: The IPC is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff
arm group label: IPC-10mmHg:
arm group label: IPC-40%
arm group label: IPC-LOP
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Paulista University
investigator full name: Franciele Marques Vanderle
investigator title: Principal Investigator
mesh term: Ischemia
sharing ipd: No