<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/NCT03232866</url>
  </required_header>
  <id_info>
    <org_study_id>69459517.8.0000.5402</org_study_id>
    <nct_id>NCT03232866</nct_id>
  </id_info>
  <brief_title>Effects of Load Monitoring on Pilates Training</brief_title>
  <official_title>Effects of Load Monitoring on Pilates Training: a Randomized Clinical Trial</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>
      There has been an increasing awareness about the need to practice some physical activity,&#xD;
      including several objectives, mainly as a preventive character. From this perspective, notice&#xD;
      the use of the Pilates method as an instrument of therapeutic exercise for the protection and&#xD;
      promotion of health. However, despite being popularly performed, there is still no scientific&#xD;
      evidence on the standardization of the use of the method and its progression to an adequate&#xD;
      prescription of physical training. The objective is monitoring the progression of loads of a&#xD;
      12-week training among the basic, intermediate and advanced levels of the Pilates method&#xD;
      through heart rate (HR), subjective exertion perception (PSE) and heart rate variability&#xD;
      (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic&#xD;
      parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the&#xD;
      initial assessment and familiarization with the method, the training period will begin&#xD;
      totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During&#xD;
      the three months, the participants must pass through the three levels of training: Basic,&#xD;
      Intermediate and Advanced. During each session, the investigators will initially collect:&#xD;
      psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory&#xD;
      parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen&#xD;
      saturation). Throughout the session a heart rate meter will be positioned on the chest of the&#xD;
      participant to capture HR, which will occur every five minutes together with the PSE&#xD;
      illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory&#xD;
      parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be&#xD;
      analyzed at baseline and after three months of training. In the case of HRV analysis, linear&#xD;
      methods in the time and frequency domain will be verified. For the statistical analysis of&#xD;
      the cardiorespiratory and autonomic parameters in the pre and post training moments will be&#xD;
      used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of&#xD;
      the training load will be used the correlation of Pearson or Sperman according to normality.&#xD;
      The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC&#xD;
      curve.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced)</measure>
    <time_frame>Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the subjective perception of effort in different levels of pilates (basic, intermediate and advanced)</measure>
    <time_frame>Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in the heart rate in different levels of pilates (basic, intermediate and advanced)</measure>
    <time_frame>Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Pilates Method</condition>
  <condition>Exercise</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>(n = 20) will practice Pilates exercises</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>(n = 20) will not carry out the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates exercise</intervention_name>
    <description>Pilates methods exercises</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male sex&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
          -  aged between 18 and 36 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>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Franciele Marques Vanderlei</name>
      <address>
        <city>Presidente Prudente</city>
        <state>São Paulo</state>
        <zip>55</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</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>PhD</investigator_title>
  </responsible_party>
  <keyword>Exercise Movement Techniques</keyword>
  <keyword>Exercise</keyword>
  <keyword>Monitoring, Physiologic</keyword>
  <keyword>Heart Rate</keyword>
  <keyword>Autonomic Nervous System</keyword>
  <keyword>Heart rate variability</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/NCT03232866
org study id: 69459517.8.0000.5402
nct id: NCT03232866
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There has been an increasing awareness about the need to practice some physical activity,
      including several objectives, mainly as a preventive character. From this perspective, notice
      the use of the Pilates method as an instrument of therapeutic exercise for the protection and
      promotion of health. However, despite being popularly performed, there is still no scientific
      evidence on the standardization of the use of the method and its progression to an adequate
      prescription of physical training. The objective is monitoring the progression of loads of a
      12-week training among the basic, intermediate and advanced levels of the Pilates method
      through heart rate (HR), subjective exertion perception (PSE) and heart rate variability
      (HRV). In addition, analyzing the effect of the method on cardiorespiratory and autonomic
      parameters. 40 healthy men aged 18-36 will receive Pilates training for 12 weeks. After the
      initial assessment and familiarization with the method, the training period will begin
      totalizing 36 sessions for three months, where each class lasts approximately 1 hour. During
      the three months, the participants must pass through the three levels of training: Basic,
      Intermediate and Advanced. During each session, the investigators will initially collect:
      psychological questionnaire, visual analogue pain scale (VAS), and cardiorespiratory
      parameters (systolic and diastolic blood pressure, HR, respiratory rate and partial oxygen
      saturation). Throughout the session a heart rate meter will be positioned on the chest of the
      participant to capture HR, which will occur every five minutes together with the PSE
      illustrated in the model proposed by Borg. At the end of each session, the cardiorespiratory
      parameters will be collected again. In addition, cardiorespiratory parameters and HRV will be
      analyzed at baseline and after three months of training. In the case of HRV analysis, linear
      methods in the time and frequency domain will be verified. For the statistical analysis of
      the cardiorespiratory and autonomic parameters in the pre and post training moments will be
      used paired t test for normal data or Wilcoxon test for non normal data. For the analysis of
      the training load will be used the correlation of Pearson or Sperman according to normality.
      The definition of cutoff points for the HRV and PSE indices will be obtained by the ROC
      curve.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline in the indices of heart rate variability in different levels of pilates (basic, intermediate and advanced)
time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
measure: Change from baseline in the subjective perception of effort in different levels of pilates (basic, intermediate and advanced)
time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
measure: Change from baseline in the heart rate in different levels of pilates (basic, intermediate and advanced)
time frame: Eight (transition from basic to intermediate level) and twelfth week (transition from intermediate to advanced level)
arm group label: Experimental group
arm group type: Experimental
description: (n = 20) will practice Pilates exercises
arm group label: Control group
arm group type: No Intervention
description: (n = 20) will not carry out the intervention
intervention type: Other
intervention name: Pilates exercise
description: Pilates methods exercises
arm group label: Experimental group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 36 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: PhD