<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/NCT04422301</url>
  </required_header>
  <id_info>
    <org_study_id>Unesp</org_study_id>
    <nct_id>NCT04422301</nct_id>
  </id_info>
  <brief_title>Correlation Between HRV and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction</brief_title>
  <official_title>Correlation Between Heart Rate Variability and Performance in Eccentric Resistance Training Associated With Partial Blood Flow Restriction: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Franciele Marques Vanderle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paulista University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Studies on resistance training (RT) associated with blood flow restriction (BFR) is an&#xD;
      alternative method of gaining strength and hypertrophy muscle. However, there is a gap&#xD;
      correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to&#xD;
      investigate this type of training in post-exercise. Objective: investigate and compare&#xD;
      autonomic and performance responses of 6 weeks of eccentric RT with different intensities&#xD;
      associated or not to BFR in healthy youngsters. Method: This is a randomized clinical trial&#xD;
      including 60 healthy men aged 18-35 years, divided into four groups according to exercise&#xD;
      intensity and BFR: 80% without BFR, 40% without BFR, 80% with BFR and 40% with BFR. Exercise&#xD;
      intensity will be determined by the peak of excentric torque on the isokinetic dynamometry&#xD;
      method and by the BFR, as being 40% of the intensity required for the complete examination of&#xD;
      the blood flow evaluated by Doppler. Participants will do an eccentric femoral quadriceps&#xD;
      muscle exercise session on the isokinetic dynamometer according to the previously randomized&#xD;
      group. For recovery analyzes, it will be used: the root-mean-square of the successive normal&#xD;
      sinus RR interval difference (rMSSD); high frequency (HF) ms²; HF(nu) and the standard&#xD;
      deviation of instantaneous beat-to-beat interval variability (SD1). For performance, it will&#xD;
      be used the single leg hop test.&#xD;
&#xD;
      For data analysis of the population profile, the descriptive statistical method will be used&#xD;
      and the results will be presented with values of means, standard deviations, median and&#xD;
      confidence interval. Initially, participants from all study groups will be dichotomized at&#xD;
      each performance outcome (muscle strength test on the isokinetic dynamometer and vertical&#xD;
      jump test) as &quot;improvement&quot; or &quot;without improvement&quot; in order to demonstrate the behavior of&#xD;
      the responses obtained during the training, that is, whether the individual responded to the&#xD;
      RT or not. It is worth mentioning that this qualitative analysis will be performed&#xD;
      considering the data obtained from the initial, intermediate and final evaluation.&#xD;
&#xD;
      The dichotomization of the results of the functional tests will be performed by the typical&#xD;
      error of the sample measurement for each test. It will be considered as &quot;improvement&quot; if the&#xD;
      participant presents gains in tests above the typical error of the measure. The values&#xD;
      obtained from the initial, intermediate and final evaluation will be analyzed independently.&#xD;
&#xD;
      Subsequently, the weekly average of the vagal indices (rMSSD, HF and SD1) will be performed&#xD;
      in the baseline moment and after 6 weeks of RT moment of each study group. In the sequence,&#xD;
      the performance parameters will be correlated with the autonomic parameters in the respective&#xD;
      groups. Pearson or Spearman correlation test will be used according to the normality of the&#xD;
      data. The level of significance will be p &lt;0.05 for all tests. The statistical program SPSS&#xD;
      (Statistical Package for the Social Sciences) will be used for the analyzes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 18, 2021</start_date>
  <completion_date type="Actual">June 18, 2021</completion_date>
  <primary_completion_date type="Actual">June 18, 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>Other</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance</measure>
    <time_frame>Baseline</time_frame>
    <description>Single Leg Hop Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance</measure>
    <time_frame>up to 3 weeks</time_frame>
    <description>Single Leg Hop Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance</measure>
    <time_frame>after 6 weeks from baseline.</time_frame>
    <description>Single Leg Hop Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HRV - rMSSD</measure>
    <time_frame>during the 6 weeks of training</time_frame>
    <description>rMSSD (square root of the mean squared differences of successive N-N intervals)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HRV - SD1</measure>
    <time_frame>during the 6 weeks of training</time_frame>
    <description>SD1 - the standard deviation of instantaneous beat-to-beat interval variability</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HRV - HF (ms²)</measure>
    <time_frame>during the 6 weeks of training</time_frame>
    <description>HF (ms²) - (high frequency)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HRV -HF (nu)</measure>
    <time_frame>during the 6 weeks of training</time_frame>
    <description>HF (nu) - (high frequency)</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>High intensity eccentric training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity eccentric training high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.&#xD;
eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High intensity eccentric training with blood flow restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High intensity eccentric training with blood flow restriction high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low intensity eccentric training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low intensity eccentric training with blood flow restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure)will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood flow restriction</intervention_name>
    <description>an alternative method to produce strength and muscle hypertrophy with lower intensities</description>
    <arm_group_label>High intensity eccentric training</arm_group_label>
    <arm_group_label>High intensity eccentric training with blood flow restriction</arm_group_label>
    <arm_group_label>Low intensity eccentric training</arm_group_label>
    <arm_group_label>Low intensity eccentric training with blood flow restriction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male sex;&#xD;
&#xD;
          -  healthy;&#xD;
&#xD;
          -  aged between 18 and 35 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  alcoholics;&#xD;
&#xD;
          -  use drugs that influenced cardiac autonomic activity;&#xD;
&#xD;
          -  cardiovascular, metabolic or endocrine diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <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>August 2021</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 30, 2021</last_update_submitted>
  <last_update_submitted_qc>August 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Paulista University</investigator_affiliation>
    <investigator_full_name>Franciele Marques Vanderle</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>resistance training</keyword>
  <keyword>vascular occlusion</keyword>
  <keyword>performance</keyword>
  <keyword>autonomic nervous system</keyword>
  <keyword>recovery of physiological function</keyword>
  <!-- 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/NCT04422301
org study id: Unesp
nct id: NCT04422301
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Studies on resistance training (RT) associated with blood flow restriction (BFR) is an
      alternative method of gaining strength and hypertrophy muscle. However, there is a gap
      correlated to autonomic repercussion of BFR and performance. Thus, it becomes relevant to
      investigate this type of training in post-exercise. Objective: investigate and compare
      autonomic and performance responses of 6 weeks of eccentric RT with different intensities
      associated or not to BFR in healthy youngsters. Method: This is a randomized clinical trial
      including 60 healthy men aged 18-35 years, divided into four groups according to exercise
      intensity and BFR: 80% without BFR, 40% without BFR, 80% with BFR and 40% with BFR. Exercise
      intensity will be determined by the peak of excentric torque on the isokinetic dynamometry
      method and by the BFR, as being 40% of the intensity required for the complete examination of
      the blood flow evaluated by Doppler. Participants will do an eccentric femoral quadriceps
      muscle exercise session on the isokinetic dynamometer according to the previously randomized
      group. For recovery analyzes, it will be used: the root-mean-square of the successive normal
      sinus RR interval difference (rMSSD); high frequency (HF) ms²; HF(nu) and the standard
      deviation of instantaneous beat-to-beat interval variability (SD1). For performance, it will
      be used the single leg hop test.

      For data analysis of the population profile, the descriptive statistical method will be used
      and the results will be presented with values of means, standard deviations, median and
      confidence interval. Initially, participants from all study groups will be dichotomized at
      each performance outcome (muscle strength test on the isokinetic dynamometer and vertical
      jump test) as "improvement" or "without improvement" in order to demonstrate the behavior of
      the responses obtained during the training, that is, whether the individual responded to the
      RT or not. It is worth mentioning that this qualitative analysis will be performed
      considering the data obtained from the initial, intermediate and final evaluation.

      The dichotomization of the results of the functional tests will be performed by the typical
      error of the sample measurement for each test. It will be considered as "improvement" if the
      participant presents gains in tests above the typical error of the measure. The values
      obtained from the initial, intermediate and final evaluation will be analyzed independently.

      Subsequently, the weekly average of the vagal indices (rMSSD, HF and SD1) will be performed
      in the baseline moment and after 6 weeks of RT moment of each study group. In the sequence,
      the performance parameters will be correlated with the autonomic parameters in the respective
      groups. Pearson or Spearman correlation test will be used according to the normality of the
      data. The level of significance will be p <0.05 for all tests. The statistical program SPSS
      (Statistical Package for the Social Sciences) will be used for the analyzes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Investigator)
measure: Performance
time frame: Baseline
description: Single Leg Hop Test
measure: Performance
time frame: up to 3 weeks
description: Single Leg Hop Test
measure: Performance
time frame: after 6 weeks from baseline.
description: Single Leg Hop Test
measure: HRV - rMSSD
time frame: during the 6 weeks of training
description: rMSSD (square root of the mean squared differences of successive N-N intervals)
measure: HRV - SD1
time frame: during the 6 weeks of training
description: SD1 - the standard deviation of instantaneous beat-to-beat interval variability
measure: HRV - HF (ms²)
time frame: during the 6 weeks of training
description: HF (ms²) - (high frequency)
measure: HRV -HF (nu)
time frame: during the 6 weeks of training
description: HF (nu) - (high frequency)
arm group label: High intensity eccentric training
arm group type: Experimental
description: High intensity eccentric training high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week.
eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
arm group label: High intensity eccentric training with blood flow restriction
arm group type: Experimental
description: High intensity eccentric training with blood flow restriction high intensity (80% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure) will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction
arm group label: Low intensity eccentric training
arm group type: Experimental
description: A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
arm group label: Low intensity eccentric training with blood flow restriction
arm group type: Experimental
description: A low intensity (40% isometric peak) eccentric training of the knee extensors in the isokinetic associated with a pressure cuff placed in the proximal thigh (40% of absolute occlusion pressure)will be performed during 6 weeks, 3 times a week. eccentric exercise with blood flow restriction High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
intervention type: Other
intervention name: Blood flow restriction
description: an alternative method to produce strength and muscle hypertrophy with lower intensities
arm group label: High intensity eccentric training
arm group label: High intensity eccentric training with blood flow restriction
arm group label: Low intensity eccentric training
arm group label: Low intensity eccentric training with blood flow restriction
criteria: 
gender: Male
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Paulista University
investigator full name: Franciele Marques Vanderle
investigator title: Clinical Professor