<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/NCT03830112</url>
  </required_header>
  <id_info>
    <org_study_id>Mat Pilates</org_study_id>
    <nct_id>NCT03830112</nct_id>
  </id_info>
  <brief_title>Effect of Two Pilates-based Mat Exercise Programs on the Isometric Strength of Core Muscles in Healthy Men</brief_title>
  <official_title>Effects of a Pilates-based Mat Exercise Program Compared to a Pilates-based Mat Exercise With Resistance Band on the Isometric Strength of Core Muscles, Lean Mass, and Body Fat in Men 18 to 25 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Antioquia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Antioquia</source>
  <oversight_info>
    <has_dmc>No</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>
      Based on the current evidence, it is known that Pilates is an exercise technique that has&#xD;
      been used mainly by women in sport, fitness and rehabilitation. Most research has been&#xD;
      developed with women. The participation of men in the research studies is reduced and&#xD;
      methodology rigor is low, therefore, there is insufficient evidence on the effects of this&#xD;
      type of training in men, in addition, there are no studies that have proven the effects of a&#xD;
      Pilates-based mat exercise with resistance band on strength of core muscles.&#xD;
&#xD;
      The main objective of this research is to identify the effects of a Pilates-based mat&#xD;
      exercise program versus a Pilates-based exercise mat program with resistance band on the&#xD;
      isometric strength of the core muscles in men 18 to 25 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fifty-eight men will be randomly assigned to one of two Pilates exercise programs.&#xD;
      Pilates-based mat exercise and Pilates-based mat exercise with Theraband® (blue color).&#xD;
      Interventions will be performed three times a week for eight-weeks on alternate days. Half&#xD;
      will perform Pilates-based mat exercise and the remaining 29 will perform Pilates-based mat&#xD;
      exercise with Theraband®. Both groups complete eleven exercises from week one to four and&#xD;
      twelve exercises from week five to eight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2018</start_date>
  <completion_date type="Actual">March 30, 2019</completion_date>
  <primary_completion_date type="Actual">February 20, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in isometric strength of the core muscles</measure>
    <time_frame>Baseline and after 8 weeks</time_frame>
    <description>Isometric strength of the core muscles will be obtained using TorsoCheck (Ergo-Fit®, Germany).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in lean mass</measure>
    <time_frame>Baseline and after 8 weeks</time_frame>
    <description>Lean mass will be obtained using Bioelectrical impedance (SECA mBCA515, Gmbh&amp;Co.,Hamburg,Germany)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body fat</measure>
    <time_frame>Baseline and after 8 weeks</time_frame>
    <description>Body fat will be obtained using Bioelectrical impedance (SECA mBCA515,Gmbh&amp;Co.,Hamburg,Germany).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Pilates exercise with Theraband</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 exercise sessions, 3x weekly (on alternate days).&#xD;
11 Pilates-based exercises with Theraband® (blue color) from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew).&#xD;
12 Pilates-based exercises with Theraband® (blue color) from week five to eight.&#xD;
(saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up).&#xD;
Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilates exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>24 exercise sessions, 3x weekly (on alternate days).&#xD;
11 Pilates-based mat exercises from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew).&#xD;
12 Pilates-based mat exercises from week five to eight. (saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up).&#xD;
Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pilates exercise with Theraband</intervention_name>
    <description>The experimental group will perform all the exercises with Theraband® in the same manner than active comparator group.</description>
    <arm_group_label>Pilates exercise with Theraband</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pilates exercise</intervention_name>
    <description>The active comparator group will perform all the exercises without Theraband®</description>
    <arm_group_label>Pilates exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers.&#xD;
&#xD;
          -  Perform ≤150 minutes of aerobic exercise per week.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perform any Pilates exercise previously.&#xD;
&#xD;
          -  Smoker.&#xD;
&#xD;
          -  History of asthma.&#xD;
&#xD;
          -  History of diabetes.&#xD;
&#xD;
          -  History of hypertension.&#xD;
&#xD;
          -  History of cardiovascular disease.&#xD;
&#xD;
          -  History of coronary heart disease.&#xD;
&#xD;
          -  Arrhythmias.&#xD;
&#xD;
          -  Under medical treatment with anticoagulants, beta-blockers, calcium antagonists,&#xD;
             bronchodilators, and/or steroids.&#xD;
&#xD;
          -  Psychological, neuromotor and/or osteo-muscular conditions that may affect&#xD;
             participation in an exercise program.&#xD;
&#xD;
          -  People with metal prosthesis.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Víctor H Arboleda Serna, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Antioquia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro de Formación en Actividad Física y Cultura</name>
      <address>
        <city>Bogotá</city>
        <state>Cundinamarca</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>June 6, 2019</last_update_submitted>
  <last_update_submitted_qc>June 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Antioquia</investigator_affiliation>
    <investigator_full_name>Victor Hugo Arboleda Serna</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03830112
org study id: Mat Pilates
nct id: NCT03830112
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Based on the current evidence, it is known that Pilates is an exercise technique that has
      been used mainly by women in sport, fitness and rehabilitation. Most research has been
      developed with women. The participation of men in the research studies is reduced and
      methodology rigor is low, therefore, there is insufficient evidence on the effects of this
      type of training in men, in addition, there are no studies that have proven the effects of a
      Pilates-based mat exercise with resistance band on strength of core muscles.

      The main objective of this research is to identify the effects of a Pilates-based mat
      exercise program versus a Pilates-based exercise mat program with resistance band on the
      isometric strength of the core muscles in men 18 to 25 years.
Fifty-eight men will be randomly assigned to one of two Pilates exercise programs.
      Pilates-based mat exercise and Pilates-based mat exercise with Theraband® (blue color).
      Interventions will be performed three times a week for eight-weeks on alternate days. Half
      will perform Pilates-based mat exercise and the remaining 29 will perform Pilates-based mat
      exercise with Theraband®. Both groups complete eleven exercises from week one to four and
      twelve exercises from week five to eight.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in isometric strength of the core muscles
time frame: Baseline and after 8 weeks
description: Isometric strength of the core muscles will be obtained using TorsoCheck (Ergo-Fit®, Germany).
measure: Change in lean mass
time frame: Baseline and after 8 weeks
description: Lean mass will be obtained using Bioelectrical impedance (SECA mBCA515, Gmbh&Co.,Hamburg,Germany)
measure: Change in body fat
time frame: Baseline and after 8 weeks
description: Body fat will be obtained using Bioelectrical impedance (SECA mBCA515,Gmbh&Co.,Hamburg,Germany).
arm group label: Pilates exercise with Theraband
arm group type: Experimental
description: 24 exercise sessions, 3x weekly (on alternate days).
11 Pilates-based exercises with Theraband® (blue color) from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew).
12 Pilates-based exercises with Theraband® (blue color) from week five to eight.
(saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up).
Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise.
arm group label: Pilates exercise
arm group type: Active Comparator
description: 24 exercise sessions, 3x weekly (on alternate days).
11 Pilates-based mat exercises from week one to four. (hundred,roll up, one leg circle,rolling like a ball,single leg stretch, double leg stretch,single straight leg stretch, double straight leg lower lift, criss-cross, spine stretch, corkscrew).
12 Pilates-based mat exercises from week five to eight. (saw, rest position, shoulder bridge, side, kick, front ad back, up and down, teaser, swimming, leg pull front, mermaid, seal, push up).
Every participant will perform three isometric repetitions of 30 seconds per exercise, with 10 seconds recovery between repetitions and 30 seconds rest between each exercise.
intervention type: Behavioral
intervention name: Pilates exercise with Theraband
description: The experimental group will perform all the exercises with Theraband® in the same manner than active comparator group.
arm group label: Pilates exercise with Theraband
intervention type: Behavioral
intervention name: Pilates exercise
description: The active comparator group will perform all the exercises without Theraband®
arm group label: Pilates exercise
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Víctor H Arboleda Serna, PhD
role: Principal Investigator
affiliation: Universidad de Antioquia
facility: 
country: Colombia
responsible party type: Principal Investigator
investigator affiliation: Universidad de Antioquia
investigator full name: Victor Hugo Arboleda Serna
investigator title: Associate Professor