<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/NCT03307031</url>
  </required_header>
  <id_info>
    <org_study_id>1.990.955</org_study_id>
    <nct_id>NCT03307031</nct_id>
  </id_info>
  <brief_title>The Influence of Pilates Exercises Training Volume on Metabolic Outcomes in Dyslipidemic Women.</brief_title>
  <official_title>The Influence of Pilates Exercises Training Volume on Metabolic, Physical Fitness and Quality of Life Outcomes in Dyslipidemic Women: A Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Rio Grande do Sul</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Rio Grande do Sul</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>
      The aim of the present study was to assess the influence of different volumes of Pilates&#xD;
      training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and&#xD;
      quality of life (QL) outcomes in postmenopausal dyslipidemic women. In total, 26 women&#xD;
      participated in the controlled clinical trial, being allocated into three groups: high volume&#xD;
      group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6). HVG performed&#xD;
      four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55&#xD;
      minutes per session. Before and after the intervention period, metabolic, BP, PF, QL and&#xD;
      cardiovascular risk score (CRS) outcomes were measured. The results were described by mean&#xD;
      values with lower and upper limits (95% confidence interval). Comparisons between groups and&#xD;
      intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post&#xD;
      hoc of Bonferroni and significance level of ɑ=0,05.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">September 13, 2017</completion_date>
  <primary_completion_date type="Actual">July 28, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>A CONTROLLED CLINICAL TRIAL</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Metabolic outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Cholesterol (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Low-density lipoprotein (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Triglycerides (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>High-density lipoprotein (mg/dl)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Metabolic outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>TC/HDL ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Systolic blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Diastolic blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Functional physical fitness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary outcomes</measure>
    <time_frame>10 weeks</time_frame>
    <description>Quality of life</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>High Volume Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performed four weekly sessions, during 10 weeks with 45 to 55 minutes per session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Volume Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Did not exercise, during 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High Volume Group</intervention_name>
    <description>Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.</description>
    <arm_group_label>High Volume Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low Volume Group</intervention_name>
    <description>Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.</description>
    <arm_group_label>Low Volume Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Did not exercise, during 10 weeks.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Dyslipidemic, postmenopausal and sedentary.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women taking statins and smokers.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Adriana Cristine Koch Buttelli</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Rio Grande do Sul</investigator_affiliation>
    <investigator_full_name>Luiz Fernando Martins Kruel</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>training volume</keyword>
  <keyword>elderly</keyword>
  <keyword>lipid profile</keyword>
  <keyword>postmenopausal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</mesh_term>
  </condition_browse>
  <!-- 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/NCT03307031
org study id: 1.990.955
nct id: NCT03307031
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present study was to assess the influence of different volumes of Pilates
      training exercises on metabolic, blood pressure (BP), functional physical fitness (PF) and
      quality of life (QL) outcomes in postmenopausal dyslipidemic women. In total, 26 women
      participated in the controlled clinical trial, being allocated into three groups: high volume
      group (HVG; n=9), low volume group (LVG; n=11) and control group (CG, n=6). HVG performed
      four weekly sessions and LVG performed only twice a week, during 10 weeks with 45 to 55
      minutes per session. Before and after the intervention period, metabolic, BP, PF, QL and
      cardiovascular risk score (CRS) outcomes were measured. The results were described by mean
      values with lower and upper limits (95% confidence interval). Comparisons between groups and
      intra-groups were performed adopting Generalized Estimating Equations (GEE) method, with post
      hoc of Bonferroni and significance level of ɑ=0,05.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: A CONTROLLED CLINICAL TRIAL
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Metabolic outcomes
time frame: 10 weeks
description: Cholesterol (mg/dl)
measure: Metabolic outcomes
time frame: 10 weeks
description: Low-density lipoprotein (mg/dl)
measure: Metabolic outcomes
time frame: 10 weeks
description: Triglycerides (mg/dl)
measure: Metabolic outcomes
time frame: 10 weeks
description: High-density lipoprotein (mg/dl)
measure: Metabolic outcomes
time frame: 10 weeks
description: TC/HDL ratio
measure: Secondary outcomes
time frame: 10 weeks
description: Systolic blood pressure (mmHg)
measure: Secondary outcomes
time frame: 10 weeks
description: Diastolic blood pressure (mmHg)
measure: Secondary outcomes
time frame: 10 weeks
description: Functional physical fitness
measure: Secondary outcomes
time frame: 10 weeks
description: Quality of life
arm group label: High Volume Group
arm group type: Experimental
description: Performed four weekly sessions, during 10 weeks with 45 to 55 minutes per session.
arm group label: Low Volume Group
arm group type: Experimental
description: Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
arm group label: Control Group
arm group type: Placebo Comparator
description: Did not exercise, during 10 weeks.
intervention type: Other
intervention name: High Volume Group
description: Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.
arm group label: High Volume Group
intervention type: Other
intervention name: Low Volume Group
description: Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
arm group label: Low Volume Group
intervention type: Other
intervention name: Control Group
description: Did not exercise, during 10 weeks.
arm group label: Control Group
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Rio Grande do Sul
investigator full name: Luiz Fernando Martins Kruel
investigator title: Doctor
mesh term: Dyslipidemias