<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/NCT02189044</url>
  </required_header>
  <id_info>
    <org_study_id>UFTM2014</org_study_id>
    <nct_id>NCT02189044</nct_id>
  </id_info>
  <brief_title>Pilates and Muscle Strength Respiratory</brief_title>
  <official_title>Effects of the Method Pilates Exercises in Muscle Strength Respiratory of Elderly Women: a Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Triangulo Mineiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Triangulo Mineiro</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Among the systems of the organism, it is believed that the respiratory system&#xD;
      is the one which gets older faster due to the greater exposure to environmental pollutants&#xD;
      over the years.The Pilates method has emerged as a form of fitness particularly providing&#xD;
      general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises&#xD;
      on respiratory muscle strength in elderly women. Methods: The investigators have studied 07&#xD;
      women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function&#xD;
      Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory&#xD;
      muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP)&#xD;
      and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment&#xD;
      lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations,&#xD;
      the investigators applied the paired t test and a significance level of 5%.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODOLOGY This study is a clinical, longitudinal, prospective trial conducted at the&#xD;
      Laboratory of Kinesiology and Cinesioterapia of Physiotherapy, Federal University of&#xD;
      Triangulo Mineiro - UFTM. All participants signed an informed consent. The research started&#xD;
      after approval by the Ethics Committee UFTM Research Protocol (2147-2012).&#xD;
&#xD;
      Subject Initially the invitation was made to all students enrolled in the Open University of&#xD;
      Third Age - UATI / UFTM from August to October 2012.&#xD;
&#xD;
      The selection was based on the following inclusion criteria: (1) age and above 60 years, (2)&#xD;
      non-practicing regular physical activity, (3) availability to attend Pilates classes twice a&#xD;
      week (in addition to the time UATI ) and (4) with preserved cognitive autonomy and exclusion&#xD;
      criteria: history (1) diseases that directly affect the posture (disc herniation and angular&#xD;
      deformities of the spine), (2) cardiovascular, respiratory and neurological diseases that&#xD;
      prevent attainment of Pilates exercises, (3) impaired cognitive capacity limited autonomy or&#xD;
      self-determination, (4) withdrawal of participation during the assessment process, and (5)&#xD;
      two consecutive absences or a total of three absences during the proposed time for the&#xD;
      training set.&#xD;
&#xD;
      Thus, the proposed methodology for this study was applied in seven women with a mean age of&#xD;
      64 ± 6 years.&#xD;
&#xD;
      Review / Procedures The assessment instruments were used: (1) Initial Assessment Sheet, (2)&#xD;
      spirometer and (3) manometer.&#xD;
&#xD;
      The record initial assessment and spirometry were applied for the selection of participants.&#xD;
      Through the initial evaluation form was possible to assess aspects of health status of&#xD;
      participants (associated diseases, blood pressure, respiratory and heart rate, postural&#xD;
      assessment) as well as information on personal history, family history and current medication&#xD;
      .&#xD;
&#xD;
      A pulmonary function test (spirometry) was performed using the Vitalograph ® spirometer brand&#xD;
      model 8600. Equipment was calibrated, and the tests were performed by a single trained and&#xD;
      qualified examiner with instructions and standardized voice commands, as I standards&#xD;
      advocated by Consensus Brazilian on Espirometria.12 Spirometry was performed to rule out any&#xD;
      lung disease that affects the performance of the proposed exercises.&#xD;
&#xD;
      To assess respiratory muscle strength, the volunteers remained in the standing position using&#xD;
      a nose clip. Respiratory muscle strength was obtained by the techniques of measurements of&#xD;
      maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), by means of an&#xD;
      analog manometer Generate brand, scaled to ± 300 cmH2O, equipped with nozzle adapter,&#xD;
      containing a hole 2 mm in diameter, serving as relief of muscles bocais.4 MIP valve was&#xD;
      obtained with the maximal inspiration preceded by maximal expiration to residual volume level&#xD;
      and MEP through the maximal expiration preceded by a maximal inspiration, to total lung&#xD;
      capacity. Were performed at least three maneuvers maximal inspiratory pressure and maximal&#xD;
      expiratory pressure, in order to obtain the greatest value from three acceptable.&#xD;
&#xD;
      The measurement of respiratory muscle strength occurred through an analog manometer (Ger-Air&#xD;
      ®, São Paulo, Brazil), with scales - 300 to +300 cmH2O (calibrated), equipped with plastic&#xD;
      trachea 16 cm long and 2.4 cm internal diameter, hard plastic mouthpiece and drain hole&#xD;
      approximately 2 mm in diameter to dissipate the pressures generated by the muscles of the&#xD;
      face and orofaringe.13 the maximal inspiratory pressure (MIP) and expiratory pressures were&#xD;
      obtained maximum (MEP), carried a maximum of five times, acceptable and reproducible, and in&#xD;
      the standing position, using a nose clip, for a time of sustained three seconds. The value of&#xD;
      MIP was obtained from residual volume, and MEP from total lung capacity. Volunteers were due&#xD;
      verbal encouragement and if there were more than 10% between a measure and another, a new&#xD;
      difference maneuver was performed, considering the highest value since this was not the&#xD;
      último.14 Therapeutic Intervention - Pilates Method The training through the Pilates&#xD;
      exercises were performed in eleven weeks. The participants were instructed not to miss and&#xD;
      attend classes twice a week. Each class consisted of five exercises lasting 40 minutes each&#xD;
      lesson.&#xD;
&#xD;
      During the first four weeks (1 st to 4 th week) exercises performed were: Cat, Coffee Table,&#xD;
      Single legcircle, pelvic movements, contraction of the glutes and closure was performed with&#xD;
      posterior chain elongation range.&#xD;
&#xD;
      In the next four weeks (5th to 8th weeks) began a new series of exercises, which are: Bridge,&#xD;
      Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and&#xD;
      ultimately Stretching - Series of William's.&#xD;
&#xD;
      In the last four weeks of training (9th to 11th weeks) proposed a new series of exercises&#xD;
      involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats&#xD;
      with bat on the wall.&#xD;
&#xD;
      All exercises were performed during expiration. Statistical Analysis Descriptive data&#xD;
      analysis was performed, with a mean and standard deviation. For comparative analysis of the&#xD;
      data obtained in the pre-and post-intervention, the paired t test was applied (after&#xD;
      confirmed the normal distribution of the sample - Shapiro Wilk test). The level of&#xD;
      significance was set at 5%. The statistical program used was 18.0 SSPSS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary function test (spirometry).</measure>
    <time_frame>The results were obtained at the end of the eleven weeks of intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory muscle strength</measure>
    <time_frame>The results were obtained at the end of the eleven weeks of intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Conditions</condition>
  <arm_group>
    <arm_group_label>exercises; muscle strength</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Evaluate the effects of Pilates exercises on respiratory muscle strength in elderly women before and after eleven weeks of training</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates Exercise</intervention_name>
    <description>The training through the Pilates exercises were performed in eleven weeks. Each class consisted of five exercises lasting 40 minutes each lesson.&#xD;
During the first four weeks exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range.&#xD;
In the next four weeks began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's.&#xD;
In the last four weeks of training proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall.</description>
    <arm_group_label>exercises; muscle strength</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age and above 60 years,&#xD;
&#xD;
          -  non-practicing regular physical activity&#xD;
&#xD;
          -  availability to attend Pilates classes twice a week (in addition to the time UATI)&#xD;
&#xD;
          -  with preserved cognitive autonomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of diseases that directly affect the posture (disc herniation and angular&#xD;
             deformities of the spine)&#xD;
&#xD;
          -  cardiovascular, respiratory and neurological diseases that prevent attainment of&#xD;
             Pilates exercises&#xD;
&#xD;
          -  impaired cognitive autonomy or limited capacity for self-determination&#xD;
&#xD;
          -  withdrawal of participation during the assessment process&#xD;
&#xD;
          -  two consecutive absences or a total of three absences during the proposed training set&#xD;
             for the time.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lislei Patrizzi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Triângulo Mineiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lislei Jorge Patrizzi</name>
      <address>
        <city>Uberaba</city>
        <state>Minas Gerais</state>
        <zip>38022200</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Triangulo Mineiro</investigator_affiliation>
    <investigator_full_name>Lislei Jorge Patrizzi</investigator_full_name>
    <investigator_title>Phd</investigator_title>
  </responsible_party>
  <keyword>aged;</keyword>
  <keyword>breathing exercises;</keyword>
  <keyword>muscle strength.</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/NCT02189044
org study id: UFTM2014
nct id: NCT02189044
lead sponsor: 
has dmc: Yes
Introduction: Among the systems of the organism, it is believed that the respiratory system
      is the one which gets older faster due to the greater exposure to environmental pollutants
      over the years.The Pilates method has emerged as a form of fitness particularly providing
      general welfare to the individual. Objective: To evaluate the effects of Pilates' exercises
      on respiratory muscle strength in elderly women. Methods: The investigators have studied 07
      women aged 60 and over, with preserved autonomy and cognitive skills. The Pulmonary Function
      Test (Spirometry) was performed using the Vitalograph® spirometer, model 8600. Respiratory
      muscle strength was obtained by technical measurements of maximal inspiratory pressure (MIP)
      and maximal expiratory pressure (MEP), through an analog Gerar manometer. The experiment
      lasted eleven (11) weeks. For comparative analysis of the data obtained in the evaluations,
      the investigators applied the paired t test and a significance level of 5%.
METHODOLOGY This study is a clinical, longitudinal, prospective trial conducted at the
      Laboratory of Kinesiology and Cinesioterapia of Physiotherapy, Federal University of
      Triangulo Mineiro - UFTM. All participants signed an informed consent. The research started
      after approval by the Ethics Committee UFTM Research Protocol (2147-2012).

      Subject Initially the invitation was made to all students enrolled in the Open University of
      Third Age - UATI / UFTM from August to October 2012.

      The selection was based on the following inclusion criteria: (1) age and above 60 years, (2)
      non-practicing regular physical activity, (3) availability to attend Pilates classes twice a
      week (in addition to the time UATI ) and (4) with preserved cognitive autonomy and exclusion
      criteria: history (1) diseases that directly affect the posture (disc herniation and angular
      deformities of the spine), (2) cardiovascular, respiratory and neurological diseases that
      prevent attainment of Pilates exercises, (3) impaired cognitive capacity limited autonomy or
      self-determination, (4) withdrawal of participation during the assessment process, and (5)
      two consecutive absences or a total of three absences during the proposed time for the
      training set.

      Thus, the proposed methodology for this study was applied in seven women with a mean age of
      64 ± 6 years.

      Review / Procedures The assessment instruments were used: (1) Initial Assessment Sheet, (2)
      spirometer and (3) manometer.

      The record initial assessment and spirometry were applied for the selection of participants.
      Through the initial evaluation form was possible to assess aspects of health status of
      participants (associated diseases, blood pressure, respiratory and heart rate, postural
      assessment) as well as information on personal history, family history and current medication
      .

      A pulmonary function test (spirometry) was performed using the Vitalograph ® spirometer brand
      model 8600. Equipment was calibrated, and the tests were performed by a single trained and
      qualified examiner with instructions and standardized voice commands, as I standards
      advocated by Consensus Brazilian on Espirometria.12 Spirometry was performed to rule out any
      lung disease that affects the performance of the proposed exercises.

      To assess respiratory muscle strength, the volunteers remained in the standing position using
      a nose clip. Respiratory muscle strength was obtained by the techniques of measurements of
      maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), by means of an
      analog manometer Generate brand, scaled to ± 300 cmH2O, equipped with nozzle adapter,
      containing a hole 2 mm in diameter, serving as relief of muscles bocais.4 MIP valve was
      obtained with the maximal inspiration preceded by maximal expiration to residual volume level
      and MEP through the maximal expiration preceded by a maximal inspiration, to total lung
      capacity. Were performed at least three maneuvers maximal inspiratory pressure and maximal
      expiratory pressure, in order to obtain the greatest value from three acceptable.

      The measurement of respiratory muscle strength occurred through an analog manometer (Ger-Air
      ®, São Paulo, Brazil), with scales - 300 to +300 cmH2O (calibrated), equipped with plastic
      trachea 16 cm long and 2.4 cm internal diameter, hard plastic mouthpiece and drain hole
      approximately 2 mm in diameter to dissipate the pressures generated by the muscles of the
      face and orofaringe.13 the maximal inspiratory pressure (MIP) and expiratory pressures were
      obtained maximum (MEP), carried a maximum of five times, acceptable and reproducible, and in
      the standing position, using a nose clip, for a time of sustained three seconds. The value of
      MIP was obtained from residual volume, and MEP from total lung capacity. Volunteers were due
      verbal encouragement and if there were more than 10% between a measure and another, a new
      difference maneuver was performed, considering the highest value since this was not the
      último.14 Therapeutic Intervention - Pilates Method The training through the Pilates
      exercises were performed in eleven weeks. The participants were instructed not to miss and
      attend classes twice a week. Each class consisted of five exercises lasting 40 minutes each
      lesson.

      During the first four weeks (1 st to 4 th week) exercises performed were: Cat, Coffee Table,
      Single legcircle, pelvic movements, contraction of the glutes and closure was performed with
      posterior chain elongation range.

      In the next four weeks (5th to 8th weeks) began a new series of exercises, which are: Bridge,
      Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and
      ultimately Stretching - Series of William's.

      In the last four weeks of training (9th to 11th weeks) proposed a new series of exercises
      involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats
      with bat on the wall.

      All exercises were performed during expiration. Statistical Analysis Descriptive data
      analysis was performed, with a mean and standard deviation. For comparative analysis of the
      data obtained in the pre-and post-intervention, the paired t test was applied (after
      confirmed the normal distribution of the sample - Shapiro Wilk test). The level of
      significance was set at 5%. The statistical program used was 18.0 SSPSS.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Pulmonary function test (spirometry).
time frame: The results were obtained at the end of the eleven weeks of intervention
measure: Respiratory muscle strength
time frame: The results were obtained at the end of the eleven weeks of intervention
arm group label: exercises; muscle strength
arm group type: Other
description: Evaluate the effects of Pilates exercises on respiratory muscle strength in elderly women before and after eleven weeks of training
intervention type: Other
intervention name: Pilates Exercise
description: The training through the Pilates exercises were performed in eleven weeks. Each class consisted of five exercises lasting 40 minutes each lesson.
During the first four weeks exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range.
In the next four weeks began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's.
In the last four weeks of training proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall.
arm group label: exercises; muscle strength
criteria: 
gender: Female
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lislei Patrizzi
role: Principal Investigator
affiliation: Universidade Federal do Triângulo Mineiro
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Triangulo Mineiro
investigator full name: Lislei Jorge Patrizzi
investigator title: Phd