<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/NCT02211001</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1159-8500</org_study_id>
    <nct_id>NCT02211001</nct_id>
  </id_info>
  <brief_title>Pilates, Postural Global Reeducation and Ball Exercises</brief_title>
  <official_title>Comparative Study of Strenght, Endurance, Flexibility of Muscle Trunk Between the Techniques: Global Postural Reeducation , Pilates and Segmented Dynamic Exercises.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate and compare the effects of three Exercise Movement&#xD;
      Techniques Global Postural Reeducation(RPG), Pilates method and Segmented Dynamic Exercises&#xD;
      (SDE) regarding muscular strength and endurance of the trunk, spine mobility and flexibility&#xD;
      of the posterior muscle chain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2010</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Abdominal Muscle Endurance: Crunch test (repetitions per minute)</measure>
    <time_frame>Baseline and week eight</time_frame>
    <description>Control Group: Baseline 30,86 Week eight 31,24 SDE Group: Baseline 25,06 Week eight 32,00 Pilates Group: Baseline 25,29 Week eight 34,14 RPG Group: Baseline 30,61 Week eight 36,17</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Extensors Muscle Endurance:Sorenson test (seconds)</measure>
    <time_frame>Baseline and week eight</time_frame>
    <description>Control Group: Baseline 69,43 Week eight 69,67 SDE Group: Baseline 72,65 Week eight 112,76 Pilates Group: Baseline 73,67 Week eight 74,43 RPG Group: Baseline 77,39 Week eight 119,48</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Toe-touch test right/left</measure>
    <time_frame>Baseline and week eight</time_frame>
    <description>Control Group: Baseline 14,61/14,87 Week eight 14,89/14,91 SDE Group: Baseline 12,95/13,2 Week eight 10,12/10,32 Pilates Group: Baseline 13,81/13,93 Week eight 11,90/12,01 RPG Group : Baseline 17,63/18,15 Week eight: 9,11/9,22</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength of trunk muscles:Peak Torque(Newton metre Nm) flexors and extensor muscles of spine measured in the isokinetic dynamometer BIODEX</measure>
    <time_frame>Baseline and week eight</time_frame>
    <description>Extension Control Group Baseline 206,1 week eight 236,9 SDE Group Baseline 213,5 week eight 239,3 Pilates Group Baseline 228,5 week eight 243,8 RPG Group Baseline 242,5 week eight 280,3&#xD;
Flexion Control Group Baseline 114,3 week eight 117,7 SDE Group Baseline 113,2 week eight 121,2 Pilates Group Baseline 109,3 week eight 118,5 RPG Group Baseline 127,2 week eight 138,1</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Strength of trunk muscles:Muscle Work (Joules) of flexors and extensor muscles of spine measured in the isokinetic dynamometer BIODEX</measure>
    <time_frame>Baseline and week eight</time_frame>
    <description>Extension Control Group Baseline 847,9 week eight 958,6 SDE Group Baseline 893,5 week eight 985,4 Pilates Group Baseline 982,1 week eight 973,0 RPG Group Baseline 1053,1 week eight 1233,0&#xD;
Flexion&#xD;
Control Group Baseline 455,8 week eight 499,8 SDE Group Baseline 492,0 week eight 491,2 Pilates Group Baseline 472,0 week eight 498,9 RPG Group Baseline 558,7 week eight 581,9</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Strength, Muscle</condition>
  <condition>Endurance , Physical</condition>
  <condition>Flexibility</condition>
  <arm_group>
    <arm_group_label>Pilates Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The individuals were treated with Mat Pilates Method.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Segmented Dynamic Exercises Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The individual were treated with ball exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Global Postural Reeducation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The individuals were treated with postures of Souchard Method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates Group</intervention_name>
    <description>The exercises were applied once a week during eight weeks.</description>
    <arm_group_label>Pilates Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Segmented Dynamic Exercises Group</intervention_name>
    <description>The exercises were applied once a week during eight weeks. once a week for eight weeks.</description>
    <arm_group_label>Segmented Dynamic Exercises Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Global Postural Reeducation</intervention_name>
    <description>The exercises were applied once a week during eight weeks.</description>
    <arm_group_label>Global Postural Reeducation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women&#xD;
&#xD;
          -  Healthy young adults who do not practice regular exercise&#xD;
&#xD;
          -  The individuals could not have prior experience with the techniques covered in this&#xD;
             study&#xD;
&#xD;
          -  They could not report a history of pain,disease, neurological or orthopedic surgeries&#xD;
             in column , upper or lower limbs, joint laxity, nor have history of injury and&#xD;
             hamstring muscles in the lower limbs, neurological disorders, obesity, rheumatic&#xD;
             disease, labyrinthitis, deformities of the lower limbs and spine&#xD;
&#xD;
          -  Individuals could not make use of drugs that affected his balance and muscle strength&#xD;
&#xD;
          -  To be framed the individual should also have restricted movement in the test distance&#xD;
             of the third finger to the ground&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with excessive absences (more than 20% of sessions) or those who missed&#xD;
             and could not reset the session in the same week were excluded -Individuals who needed&#xD;
             to undergo some surgery or any medical treatment during the duration of the study, or&#xD;
             those who give up without completing the minimum time of the intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cintia de Freitas, student</last_name>
    <role>Principal Investigator</role>
    <affiliation>FMUSP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculdade de Medicina da Universidade de São Paulo</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Kloubec JA. Pilates for improvement of muscle endurance, flexibility, balance, and posture. J Strength Cond Res. 2010 Mar;24(3):661-7. doi: 10.1519/JSC.0b013e3181c277a6.</citation>
    <PMID>20145572</PMID>
  </reference>
  <results_reference>
    <citation>Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.</citation>
    <PMID>17304690</PMID>
  </results_reference>
  <results_reference>
    <citation>Marshall PW, Murphy BA. Core stability exercises on and off a Swiss ball. Arch Phys Med Rehabil. 2005 Feb;86(2):242-9. doi: 10.1016/j.apmr.2004.05.004.</citation>
    <PMID>15706550</PMID>
  </results_reference>
  <results_reference>
    <citation>Carter JM, Beam WC, McMahan SG, Barr ML, Brown LE. The effects of stability ball training on spinal stability in sedentary individuals. J Strength Cond Res. 2006 May;20(2):429-35. doi: 10.1519/R-18125.1.</citation>
    <PMID>16686575</PMID>
  </results_reference>
  <results_reference>
    <citation>Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.</citation>
    <PMID>22030232</PMID>
  </results_reference>
  <results_reference>
    <citation>Vanti C, Generali A, Ferrari S, Nava T, Tosarelli D, Pillastrini P. [ General postural rehabilitation in musculoskeletal diseases: scientific evidence and clinical indications]. Reumatismo. 2007 Jul-Sep;59(3):192-201. Italian.</citation>
    <PMID>17898878</PMID>
  </results_reference>
  <results_reference>
    <citation>Oliveri M, Caltagirone C, Loriga R, Pompa MN, Versace V, Souchard P. Fast increase of motor cortical inhibition following postural changes in healthy subjects. Neurosci Lett. 2012 Nov 14;530(1):7-11. doi: 10.1016/j.neulet.2012.09.031. Epub 2012 Sep 28.</citation>
    <PMID>23022506</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 5, 2014</last_update_submitted>
  <last_update_submitted_qc>August 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Cintia Domingues de Freitas</investigator_full_name>
    <investigator_title>Physical Therapist</investigator_title>
  </responsible_party>
  <keyword>Exercise Movement Techniques</keyword>
  <keyword>Exercise Therapy</keyword>
  <keyword>Physical Therapy Modalities.</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/NCT02211001
org study id: U1111-1159-8500
nct id: NCT02211001
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate and compare the effects of three Exercise Movement
      Techniques Global Postural Reeducation(RPG), Pilates method and Segmented Dynamic Exercises
      (SDE) regarding muscular strength and endurance of the trunk, spine mobility and flexibility
      of the posterior muscle chain.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Abdominal Muscle Endurance: Crunch test (repetitions per minute)
time frame: Baseline and week eight
description: Control Group: Baseline 30,86 Week eight 31,24 SDE Group: Baseline 25,06 Week eight 32,00 Pilates Group: Baseline 25,29 Week eight 34,14 RPG Group: Baseline 30,61 Week eight 36,17
measure: Extensors Muscle Endurance:Sorenson test (seconds)
time frame: Baseline and week eight
description: Control Group: Baseline 69,43 Week eight 69,67 SDE Group: Baseline 72,65 Week eight 112,76 Pilates Group: Baseline 73,67 Week eight 74,43 RPG Group: Baseline 77,39 Week eight 119,48
measure: Toe-touch test right/left
time frame: Baseline and week eight
description: Control Group: Baseline 14,61/14,87 Week eight 14,89/14,91 SDE Group: Baseline 12,95/13,2 Week eight 10,12/10,32 Pilates Group: Baseline 13,81/13,93 Week eight 11,90/12,01 RPG Group : Baseline 17,63/18,15 Week eight: 9,11/9,22
measure: Strength of trunk muscles:Peak Torque(Newton metre Nm) flexors and extensor muscles of spine measured in the isokinetic dynamometer BIODEX
time frame: Baseline and week eight
description: Extension Control Group Baseline 206,1 week eight 236,9 SDE Group Baseline 213,5 week eight 239,3 Pilates Group Baseline 228,5 week eight 243,8 RPG Group Baseline 242,5 week eight 280,3
Flexion Control Group Baseline 114,3 week eight 117,7 SDE Group Baseline 113,2 week eight 121,2 Pilates Group Baseline 109,3 week eight 118,5 RPG Group Baseline 127,2 week eight 138,1
measure: Strength of trunk muscles:Muscle Work (Joules) of flexors and extensor muscles of spine measured in the isokinetic dynamometer BIODEX
time frame: Baseline and week eight
description: Extension Control Group Baseline 847,9 week eight 958,6 SDE Group Baseline 893,5 week eight 985,4 Pilates Group Baseline 982,1 week eight 973,0 RPG Group Baseline 1053,1 week eight 1233,0
Flexion
Control Group Baseline 455,8 week eight 499,8 SDE Group Baseline 492,0 week eight 491,2 Pilates Group Baseline 472,0 week eight 498,9 RPG Group Baseline 558,7 week eight 581,9
arm group label: Pilates Group
arm group type: Experimental
description: The individuals were treated with Mat Pilates Method.
arm group label: Segmented Dynamic Exercises Group
arm group type: Experimental
description: The individual were treated with ball exercises.
arm group label: Global Postural Reeducation Group
arm group type: Experimental
description: The individuals were treated with postures of Souchard Method.
intervention type: Other
intervention name: Pilates Group
description: The exercises were applied once a week during eight weeks.
arm group label: Pilates Group
intervention type: Other
intervention name: Segmented Dynamic Exercises Group
description: The exercises were applied once a week during eight weeks. once a week for eight weeks.
arm group label: Segmented Dynamic Exercises Group
intervention type: Other
intervention name: Global Postural Reeducation
description: The exercises were applied once a week during eight weeks.
arm group label: Global Postural Reeducation Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cintia de Freitas, student
role: Principal Investigator
affiliation: FMUSP
facility: 
country: Brazil
citation: Kloubec JA. Pilates for improvement of muscle endurance, flexibility, balance, and posture. J Strength Cond Res. 2010 Mar;24(3):661-7. doi: 10.1519/JSC.0b013e3181c277a6.
PMID: 20145572
citation: Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.
PMID: 17304690
citation: Marshall PW, Murphy BA. Core stability exercises on and off a Swiss ball. Arch Phys Med Rehabil. 2005 Feb;86(2):242-9. doi: 10.1016/j.apmr.2004.05.004.
PMID: 15706550
citation: Carter JM, Beam WC, McMahan SG, Barr ML, Brown LE. The effects of stability ball training on spinal stability in sedentary individuals. J Strength Cond Res. 2006 May;20(2):429-35. doi: 10.1519/R-18125.1.
PMID: 16686575
citation: Cruz-Ferreira A, Fernandes J, Laranjo L, Bernardo LM, Silva A. A systematic review of the effects of pilates method of exercise in healthy people. Arch Phys Med Rehabil. 2011 Dec;92(12):2071-81. doi: 10.1016/j.apmr.2011.06.018. Epub 2011 Oct 24.
PMID: 22030232
citation: Vanti C, Generali A, Ferrari S, Nava T, Tosarelli D, Pillastrini P. [ General postural rehabilitation in musculoskeletal diseases: scientific evidence and clinical indications]. Reumatismo. 2007 Jul-Sep;59(3):192-201. Italian.
PMID: 17898878
citation: Oliveri M, Caltagirone C, Loriga R, Pompa MN, Versace V, Souchard P. Fast increase of motor cortical inhibition following postural changes in healthy subjects. Neurosci Lett. 2012 Nov 14;530(1):7-11. doi: 10.1016/j.neulet.2012.09.031. Epub 2012 Sep 28.
PMID: 23022506
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Cintia Domingues de Freitas
investigator title: Physical Therapist