<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/NCT03791502</url>
  </required_header>
  <id_info>
    <org_study_id>MP2018</org_study_id>
    <nct_id>NCT03791502</nct_id>
  </id_info>
  <brief_title>Effect of Different Volumes of Training of Pilates Exercises on Elderly</brief_title>
  <official_title>Effect of Different Volumes of Training of Pilates Exercises on Muscle Strength, Postural Balance, Flexibility, Functional Autonomy, Depressive Symptoms and Pulmonary Function on Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Brasilia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Brasilia</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>
      It will be an experimental study conducted with elderly of both sexes, these will be divided&#xD;
      randomly into three groups and the intervention will happen twice a week, for 60 minutes, for&#xD;
      12 weeks. The aim of the study is to compare the effect of different volumes of Pilates&#xD;
      exercise training on muscle strength, postural balance, flexibility, functional autonomy,&#xD;
      depressive symptoms and lung function in the elderly community. The investigators believe&#xD;
      that Pilates exercises will have beneficial effects for the elderly, but the hypothesis is&#xD;
      that the group that performs a greater volume of Pilates exercise training will have a&#xD;
      greater improvement in the investigated outcomes than the group with the lowest volume.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aging is an involuntary and progressive process that leads to biological, structural and&#xD;
      functional changes such as loss of mass and muscle strength. The aging process leads to&#xD;
      changes in the visual, vestibular, sensory and motor systems, causing slow reaction time,&#xD;
      compromising the postural balance. Flexibility and mobility also tend to decrease with aging&#xD;
      favoring the onset of lesions and loss of functional autonomy. The regular practice of&#xD;
      physical exercise helps to prevent these changes related to aging. Among the various&#xD;
      possibilities of physical exercise, the Pilates method has been well-suited for the elderly,&#xD;
      since it incorporates the training components recommended by the American College of Sports&#xD;
      Medicine (ACSM), is the strength, balance, and flexibility. However, researchers have&#xD;
      questioned the lack of scientific evidence that confirms all the benefits of the method,&#xD;
      especially in the elderly. The findings described in the literature are still controversial.&#xD;
      A systematic review of six randomized controlled trials (RCTs) has shown limited evidence in&#xD;
      improving strength, flexibility, and balance in both sexes.&#xD;
&#xD;
      Physical decline negatively affects the personal autonomy and quality of life of the elderly&#xD;
      and Pilates seems to have positive effects on these aspects. Rodrigues et al. (2010) observed&#xD;
      a significant evolution in the functional performance of healthy elderly women in rising from&#xD;
      the seated position (11.8%) and lying position (26%) and a significant improvement in quality&#xD;
      of life (p = 0.04) after intervention with Pilates exercises . As for depressive symptoms,&#xD;
      Mokhtari et al. (2013) identified a significant reduction (p &lt;0.007) in this symptomatology&#xD;
      after Pilates practice. However, both studies reached only two points on the PEDro Scale.&#xD;
      Recent investigations found a significant increase in maximal inspiratory pressure (MIP) of&#xD;
      19.5%, maximal expiratory pressure (MEP) of 8.7% and Abdominal Transversal thickness of 42.3%&#xD;
      after the program. However, the study presented some limitations, such as the absence of a&#xD;
      control group and the inability of the blindness of the evaluators.&#xD;
&#xD;
      It is also important to highlight the lack of reports on how the programs are carried out and&#xD;
      when there is a description there is a heterogeneity in the prescription of the exercises. In&#xD;
      the two reviews cited above, only two of the included studies presented the prescribed&#xD;
      volume: ten replicates and three series of ten repetitions. Some studies have also described&#xD;
      the volume: two sets of ten repetitions, two to four sets of 15 to 20 seconds of contraction&#xD;
      for isometric exercises and 15 to 20 repetitions for dynamic exercises. A single series of 10&#xD;
      replicates with a 30-second interval between the series. It is known that the literature&#xD;
      suggests for the muscular strength gain in the elderly a training volume of two to three sets&#xD;
      per exercise, seven to ten repetitions per set and a moderate to high intensity and as noted&#xD;
      most Pilates exercise programs have not followed these recommendations. The aim of the study&#xD;
      is to compare the effect of different volumes of Pilates exercise training on muscle&#xD;
      strength, postural balance, flexibility, functional autonomy, depressive symptoms and lung&#xD;
      function in the elderly community.&#xD;
&#xD;
      The elderly will be invited through advertisements in social networks, local media, and&#xD;
      posters distributed in the centers for the coexistence of the elderly, health centers and&#xD;
      churches. Initially, each individual who agrees to participate in the study will sign the&#xD;
      Free and Informed Consent Form. Next, the investigators will collect the data referring to&#xD;
      the variables: cognitive aptitude, sociodemographic, clinical characterization, and&#xD;
      anthropometric measurements. All participants will be evaluated for muscle strength, balance,&#xD;
      flexibility, functional autonomy, depression and lung function before and after the&#xD;
      intervention, including those who do not complete 80% of their presence during the&#xD;
      intervention period. For the self-report questionnaires an evaluator will be trained and for&#xD;
      the performance questionnaires/tests two evaluators will be trained and they will be blind to&#xD;
      the intervention.&#xD;
&#xD;
      The risks of participating in the research are: the participants feel embarrassed in some&#xD;
      interview questions, present some imbalance and risk of falls, muscle aches and increased&#xD;
      blood pressure (BP) and heart rate (HR). However, to minimize them, the participant may&#xD;
      refuse to answer any of the questions and interrupt the interview, as each position of the&#xD;
      balance tests the interviewer will first demonstrate the task, then support the participants&#xD;
      and only withdraw support after the consent of the participant, always standing next to it.&#xD;
      The stretching will be performed in case of muscle discomfort and the monitoring of&#xD;
      cardiorespiratory variables will be done.&#xD;
&#xD;
      How much of the benefits will participants be contributing to a greater knowledge about the&#xD;
      effects of Pilates exercises in the elderly, the results obtained with the research will&#xD;
      favor the formulation of adequate exercise programs and an improvement of care for the&#xD;
      elderly, improving the quality of care, in the prevention of functional problems and falls.&#xD;
      In addition, participants will have a thorough assessment of their overall health,&#xD;
      well-being, and physical and functional aspects and may improve the deficiencies presented by&#xD;
      performing Pilates exercises. Pilates will promote improved strength, muscular flexibility&#xD;
      and well-being and provide socialization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2019</start_date>
  <completion_date type="Actual">December 2, 2019</completion_date>
  <primary_completion_date type="Actual">October 2, 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>
    <intervention_model_description>Subjects will be randomized into three groups, two intervention groups and one group will be the control. The randomization process will be done by a person who does not participate in the survey, at random.org, and concealment of the allocation will occur using opaque and sealed envelopes.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in muscle strength of lower limbs</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Biofeedback System will be used for the practice of resistance exercises with elastic overload (E-lastic®). E-lastic® will measure maximal isometric voluntary contraction of the knee flexor and extensor muscles, flexors, extensors, adductors and hip abductors before and after the intervention. For the acquisition of force signals, a load cell is used to provide an electrical signal proportional to the force that deforms the equipment. The participants will perform 3 repetitions, maintaining the contraction for 5 seconds, with 60 seconds of recovery and the highest value will be recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in muscle strength and resistance of lower limbs</measure>
    <time_frame>12 weeks</time_frame>
    <description>The 30-second chair stand test (30-s CST) will be used. It consists of getting up and sitting on a chair as many times as possible within 30 seconds. A seat with backrest and without armrest (with a seat height of 45 cm) is used. Initially, participants remain seated and are instructed to look forward after command &quot;1, 2, 3, will&quot; they raise with their arms crossed on their chest. The evaluator will explain and demonstrate the test and the participant will do once for familiarization. You will be given a rest of 2 minutes to start the test.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in palmar grip strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Will be measured using the Saehan® hydraulic palmar gripper dynamometer, the position recommended by the American Society of Hand Therapists (ASHT) will be adopted: sitting comfortably positioned with shoulder lightly bent, elbow bent at 90 °, forearm in neutral position and, finally, the position of the handle may vary from 0 ° to 30 ° of extension. It will be used to record the maximum and average manual grip strength of three measurements and the values will be compared with the reference values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in static postural balance</measure>
    <time_frame>12 weeks</time_frame>
    <description>The static balance will be evaluated by measuring the time each participant can maintain in three progressively more difficult positions: semi-tandem, tandem and unipedal support. In all positions the individuals must be with their hands on their waist, the total time to stay in each position is 30 seconds and it will have 3 attempts in each position and the best time will be recorded. The evaluator will demonstrate the test once.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dynamic postural balance (TUG)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the dynamic balance, the Timed Up and Go Test (TUG) will be used. The TUG starts with the participant sitting in the chair, in the &quot;go&quot; command, he gets up from the chair, walks 3 meters at a comfortable pace, turns around, goes back to the chair and sits down. It will be demonstrated once and then it will do a repeat for familiarization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in dynamic postural balance (Step)</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the dynamic balance, the Step Test will be used. The Alternative Step Test the participant is asked to make eight beats of foot, alternating between right and left, on a step in front of him with a height of 18 cm. Time will be timed and used in the analyzes. The test should be performed in 10 seconds.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in flexibility</measure>
    <time_frame>12 weeks</time_frame>
    <description>To evaluate the flexibility of the hamstring muscles will be used the Sit and Go Test, using the Wells bench, participants will remain without footwear, sitting with knees extended, shoulders flexed, elbows extended and hands overlapped. Participants should perform trunk flexion at the front, perform a forced expiration, and move the seat ladder as far as possible, this procedure will be performed three times and immediately noted by the evaluator, with the best.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional Autonomy</measure>
    <time_frame>12 weeks</time_frame>
    <description>The functional autonomy of the upper limbs will be evaluated by the dressing test and a t-shirt. Initially the evaluator will explain the test and the volunteer will do a brief training with two replicates. The execution time is marked in seconds and the shorter the execution time, the better the result. The subject must make two attempts, where the best performance attempt will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms</measure>
    <time_frame>12 weeks</time_frame>
    <description>The Geriatric Depression Scale will be used for the evaluation of depressive symptoms in the elderly and screening for depression among older people. Geriatric depression scale will be presented as an interview and the questions have a yes / no format to be easy to understand. The short version consists of 15 questions, one point is given for each &quot;yes&quot; answer and the number of points is added to provide a single score. The score ranges from 0 to 15 and a score of zero to five is considered normal, six to ten indicates mild depression and 11 to 15 suggests severe depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in respiratory muscle strength</measure>
    <time_frame>12 weeks</time_frame>
    <description>Respiratory muscle strength will be measured by assessing maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in cmH2O. These measures represent the strength of the inspiratory and expiratory muscles respectively. It will be using the manometer of the brand Globalmed® MVD300, calibrated, patient seated at 90º, a nasal clip and a nozzle connected to the equipment will be placed. In order to assess MIP, a maximum expiration up to the residual volume and, in the sequence, a maximum sustained forced inspiration will be required. And to assess PEmax inspiration will be required up to the total lung capacity and, subsequently, a forced maximum expiration up to the residual volume. Three reproducible measurements will be made, with variation less than 10% and the values found will be compared with those predicted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary function (FVC)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pulmonary function will also be evaluated by spirometry. The test measures forced vital capacity (FVC) in liters (L). A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary function (FEV1)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pulmonary function will also be evaluated by spirometry. The test measures the forced expiratory volume in the first second (FEV1) in liters (L). A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pulmonary function (FEV1 / FVC ratio)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pulmonary function will also be evaluated by spirometry. The test measures the FEV1 / FVC ratio. A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Aging</condition>
  <condition>Exercise Movement Techniques</condition>
  <arm_group>
    <arm_group_label>Pilates Method Exercises - lower volume</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The prescription will consist of 18 exercises, performed in a single series of seven to 10 repetitions, 60 seconds rest between exercises. Each week the exercises will be changed and the same exercise can only be repeated every three weeks. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises, but without modifying the repetitions. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pilates Method Exercises - higher volume</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will conduct a Pilates exercise program based on the recommendations of the American College Medicine of Sports. The prescription will consist of 12 exercises, performed in three sets of seven to ten repetitions and 60s of rest between sets. Every four weeks the exercises will be changed. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The subjects allocated in the control group will remain with their usual activities, and after the reevaluation will be offered the intervention that presents the greater size of effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates Method Exercises</intervention_name>
    <description>Pilates Method exercises performed on the apparatus, on the ground and with accessories. They will always be performed by a physiotherapist with teaching certification in the Pilates methodology and will be supervised by two properly trained physiotherapy trainees. Participants will start the exercise program in small groups of up to 8 people, twice a week for 60 minutes, for 12 weeks, totaling 24 sessions. The first day of intervention for both groups will be devoted to explaining the six principles described by Joseph Pilates: centralization, concentration, control, precision, fluidity and breathing, and some fundamentals such as the neutral position of the spine. And in all sessions, these principles will be remembered by the physiotherapist.</description>
    <arm_group_label>Pilates Method Exercises - higher volume</arm_group_label>
    <arm_group_label>Pilates Method Exercises - lower volume</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To present cognitive aptitude according to the Mental State Mini-Exam (MMSE)&#xD;
&#xD;
          -  Independent walking, without the use of auxiliary walking devices;&#xD;
&#xD;
          -  Not participating in other physical intervention research;&#xD;
&#xD;
          -  Not having undergone physiotherapeutic treatment and not having participated in a&#xD;
             structured physical activity in the previous month;&#xD;
&#xD;
          -  Do not present neurological diseases, history of fractures or recent surgeries and&#xD;
             serious cardiorespiratory diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to attend all stages of evaluation;&#xD;
&#xD;
          -  They did not complete 80% of the intervention;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mônica D Caetano</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Brasilia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mônica Batista Duarte Caetano</name>
      <address>
        <city>Goiânia</city>
        <state>Goiás</state>
        <zip>74343530</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
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    <citation>Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52.</citation>
    <PMID>12620088</PMID>
  </reference>
  <reference>
    <citation>McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM. Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004 Nov;59(11):1207-12. doi: 10.1093/gerona/59.11.1207.</citation>
    <PMID>15602077</PMID>
  </reference>
  <reference>
    <citation>Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.</citation>
    <PMID>22579438</PMID>
  </reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>February 1, 2020</last_update_submitted>
  <last_update_submitted_qc>February 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Brasilia</investigator_affiliation>
    <investigator_full_name>Mônica Batista Duarte Caetano</investigator_full_name>
    <investigator_title>Postgraduate Student of the Post-graduation Program in Rehabilitation Sciences da University de Brasilia</investigator_title>
  </responsible_party>
  <keyword>Exercise Movement Techniques</keyword>
  <keyword>Elderly</keyword>
  <keyword>Muscular Strength</keyword>
  <keyword>Postural Balance</keyword>
  <keyword>Flexibility</keyword>
  <keyword>Pilates</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03791502/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03791502
org study id: MP2018
nct id: NCT03791502
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
It will be an experimental study conducted with elderly of both sexes, these will be divided
      randomly into three groups and the intervention will happen twice a week, for 60 minutes, for
      12 weeks. The aim of the study is to compare the effect of different volumes of Pilates
      exercise training on muscle strength, postural balance, flexibility, functional autonomy,
      depressive symptoms and lung function in the elderly community. The investigators believe
      that Pilates exercises will have beneficial effects for the elderly, but the hypothesis is
      that the group that performs a greater volume of Pilates exercise training will have a
      greater improvement in the investigated outcomes than the group with the lowest volume.
Aging is an involuntary and progressive process that leads to biological, structural and
      functional changes such as loss of mass and muscle strength. The aging process leads to
      changes in the visual, vestibular, sensory and motor systems, causing slow reaction time,
      compromising the postural balance. Flexibility and mobility also tend to decrease with aging
      favoring the onset of lesions and loss of functional autonomy. The regular practice of
      physical exercise helps to prevent these changes related to aging. Among the various
      possibilities of physical exercise, the Pilates method has been well-suited for the elderly,
      since it incorporates the training components recommended by the American College of Sports
      Medicine (ACSM), is the strength, balance, and flexibility. However, researchers have
      questioned the lack of scientific evidence that confirms all the benefits of the method,
      especially in the elderly. The findings described in the literature are still controversial.
      A systematic review of six randomized controlled trials (RCTs) has shown limited evidence in
      improving strength, flexibility, and balance in both sexes.

      Physical decline negatively affects the personal autonomy and quality of life of the elderly
      and Pilates seems to have positive effects on these aspects. Rodrigues et al. (2010) observed
      a significant evolution in the functional performance of healthy elderly women in rising from
      the seated position (11.8%) and lying position (26%) and a significant improvement in quality
      of life (p = 0.04) after intervention with Pilates exercises . As for depressive symptoms,
      Mokhtari et al. (2013) identified a significant reduction (p <0.007) in this symptomatology
      after Pilates practice. However, both studies reached only two points on the PEDro Scale.
      Recent investigations found a significant increase in maximal inspiratory pressure (MIP) of
      19.5%, maximal expiratory pressure (MEP) of 8.7% and Abdominal Transversal thickness of 42.3%
      after the program. However, the study presented some limitations, such as the absence of a
      control group and the inability of the blindness of the evaluators.

      It is also important to highlight the lack of reports on how the programs are carried out and
      when there is a description there is a heterogeneity in the prescription of the exercises. In
      the two reviews cited above, only two of the included studies presented the prescribed
      volume: ten replicates and three series of ten repetitions. Some studies have also described
      the volume: two sets of ten repetitions, two to four sets of 15 to 20 seconds of contraction
      for isometric exercises and 15 to 20 repetitions for dynamic exercises. A single series of 10
      replicates with a 30-second interval between the series. It is known that the literature
      suggests for the muscular strength gain in the elderly a training volume of two to three sets
      per exercise, seven to ten repetitions per set and a moderate to high intensity and as noted
      most Pilates exercise programs have not followed these recommendations. The aim of the study
      is to compare the effect of different volumes of Pilates exercise training on muscle
      strength, postural balance, flexibility, functional autonomy, depressive symptoms and lung
      function in the elderly community.

      The elderly will be invited through advertisements in social networks, local media, and
      posters distributed in the centers for the coexistence of the elderly, health centers and
      churches. Initially, each individual who agrees to participate in the study will sign the
      Free and Informed Consent Form. Next, the investigators will collect the data referring to
      the variables: cognitive aptitude, sociodemographic, clinical characterization, and
      anthropometric measurements. All participants will be evaluated for muscle strength, balance,
      flexibility, functional autonomy, depression and lung function before and after the
      intervention, including those who do not complete 80% of their presence during the
      intervention period. For the self-report questionnaires an evaluator will be trained and for
      the performance questionnaires/tests two evaluators will be trained and they will be blind to
      the intervention.

      The risks of participating in the research are: the participants feel embarrassed in some
      interview questions, present some imbalance and risk of falls, muscle aches and increased
      blood pressure (BP) and heart rate (HR). However, to minimize them, the participant may
      refuse to answer any of the questions and interrupt the interview, as each position of the
      balance tests the interviewer will first demonstrate the task, then support the participants
      and only withdraw support after the consent of the participant, always standing next to it.
      The stretching will be performed in case of muscle discomfort and the monitoring of
      cardiorespiratory variables will be done.

      How much of the benefits will participants be contributing to a greater knowledge about the
      effects of Pilates exercises in the elderly, the results obtained with the research will
      favor the formulation of adequate exercise programs and an improvement of care for the
      elderly, improving the quality of care, in the prevention of functional problems and falls.
      In addition, participants will have a thorough assessment of their overall health,
      well-being, and physical and functional aspects and may improve the deficiencies presented by
      performing Pilates exercises. Pilates will promote improved strength, muscular flexibility
      and well-being and provide socialization.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized into three groups, two intervention groups and one group will be the control. The randomization process will be done by a person who does not participate in the survey, at random.org, and concealment of the allocation will occur using opaque and sealed envelopes.
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Change in muscle strength of lower limbs
time frame: 12 weeks
description: The Biofeedback System will be used for the practice of resistance exercises with elastic overload (E-lastic®). E-lastic® will measure maximal isometric voluntary contraction of the knee flexor and extensor muscles, flexors, extensors, adductors and hip abductors before and after the intervention. For the acquisition of force signals, a load cell is used to provide an electrical signal proportional to the force that deforms the equipment. The participants will perform 3 repetitions, maintaining the contraction for 5 seconds, with 60 seconds of recovery and the highest value will be recorded.
measure: change in muscle strength and resistance of lower limbs
time frame: 12 weeks
description: The 30-second chair stand test (30-s CST) will be used. It consists of getting up and sitting on a chair as many times as possible within 30 seconds. A seat with backrest and without armrest (with a seat height of 45 cm) is used. Initially, participants remain seated and are instructed to look forward after command "1, 2, 3, will" they raise with their arms crossed on their chest. The evaluator will explain and demonstrate the test and the participant will do once for familiarization. You will be given a rest of 2 minutes to start the test.
measure: Change in palmar grip strength
time frame: 12 weeks
description: Will be measured using the Saehan® hydraulic palmar gripper dynamometer, the position recommended by the American Society of Hand Therapists (ASHT) will be adopted: sitting comfortably positioned with shoulder lightly bent, elbow bent at 90 °, forearm in neutral position and, finally, the position of the handle may vary from 0 ° to 30 ° of extension. It will be used to record the maximum and average manual grip strength of three measurements and the values will be compared with the reference values.
measure: Change in static postural balance
time frame: 12 weeks
description: The static balance will be evaluated by measuring the time each participant can maintain in three progressively more difficult positions: semi-tandem, tandem and unipedal support. In all positions the individuals must be with their hands on their waist, the total time to stay in each position is 30 seconds and it will have 3 attempts in each position and the best time will be recorded. The evaluator will demonstrate the test once.
measure: Change in dynamic postural balance (TUG)
time frame: 12 weeks
description: To evaluate the dynamic balance, the Timed Up and Go Test (TUG) will be used. The TUG starts with the participant sitting in the chair, in the "go" command, he gets up from the chair, walks 3 meters at a comfortable pace, turns around, goes back to the chair and sits down. It will be demonstrated once and then it will do a repeat for familiarization.
measure: Change in dynamic postural balance (Step)
time frame: 12 weeks
description: To evaluate the dynamic balance, the Step Test will be used. The Alternative Step Test the participant is asked to make eight beats of foot, alternating between right and left, on a step in front of him with a height of 18 cm. Time will be timed and used in the analyzes. The test should be performed in 10 seconds.
measure: Change in flexibility
time frame: 12 weeks
description: To evaluate the flexibility of the hamstring muscles will be used the Sit and Go Test, using the Wells bench, participants will remain without footwear, sitting with knees extended, shoulders flexed, elbows extended and hands overlapped. Participants should perform trunk flexion at the front, perform a forced expiration, and move the seat ladder as far as possible, this procedure will be performed three times and immediately noted by the evaluator, with the best.
measure: Functional Autonomy
time frame: 12 weeks
description: The functional autonomy of the upper limbs will be evaluated by the dressing test and a t-shirt. Initially the evaluator will explain the test and the volunteer will do a brief training with two replicates. The execution time is marked in seconds and the shorter the execution time, the better the result. The subject must make two attempts, where the best performance attempt will be recorded.
measure: Depressive symptoms
time frame: 12 weeks
description: The Geriatric Depression Scale will be used for the evaluation of depressive symptoms in the elderly and screening for depression among older people. Geriatric depression scale will be presented as an interview and the questions have a yes / no format to be easy to understand. The short version consists of 15 questions, one point is given for each "yes" answer and the number of points is added to provide a single score. The score ranges from 0 to 15 and a score of zero to five is considered normal, six to ten indicates mild depression and 11 to 15 suggests severe depression.
measure: Change in respiratory muscle strength
time frame: 12 weeks
description: Respiratory muscle strength will be measured by assessing maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) in cmH2O. These measures represent the strength of the inspiratory and expiratory muscles respectively. It will be using the manometer of the brand Globalmed® MVD300, calibrated, patient seated at 90º, a nasal clip and a nozzle connected to the equipment will be placed. In order to assess MIP, a maximum expiration up to the residual volume and, in the sequence, a maximum sustained forced inspiration will be required. And to assess PEmax inspiration will be required up to the total lung capacity and, subsequently, a forced maximum expiration up to the residual volume. Three reproducible measurements will be made, with variation less than 10% and the values found will be compared with those predicted.
measure: Change in pulmonary function (FVC)
time frame: 12 weeks
description: Pulmonary function will also be evaluated by spirometry. The test measures forced vital capacity (FVC) in liters (L). A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations
measure: Change in pulmonary function (FEV1)
time frame: 12 weeks
description: Pulmonary function will also be evaluated by spirometry. The test measures the forced expiratory volume in the first second (FEV1) in liters (L). A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations
measure: Change in pulmonary function (FEV1 / FVC ratio)
time frame: 12 weeks
description: Pulmonary function will also be evaluated by spirometry. The test measures the FEV1 / FVC ratio. A One Flow® portable spirometer will be used, the individual will be seated with the head in the neutral position, inspiration will be requested up to the total lung capacity (CPT) and, thereafter, a maximum expiration, with an explosive start, to the residual volume (lasting at least 6 seconds). A maximum of eight replications will be performed until three reproducible measures (less than 10% difference), 60 seconds of interval between measurements, will be considered the best value. It is recommended to compare the values obtained with predicted equations
arm group label: Pilates Method Exercises - lower volume
arm group type: Experimental
description: The prescription will consist of 18 exercises, performed in a single series of seven to 10 repetitions, 60 seconds rest between exercises. Each week the exercises will be changed and the same exercise can only be repeated every three weeks. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises, but without modifying the repetitions. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.
arm group label: Pilates Method Exercises - higher volume
arm group type: Experimental
description: The participants will conduct a Pilates exercise program based on the recommendations of the American College Medicine of Sports. The prescription will consist of 12 exercises, performed in three sets of seven to ten repetitions and 60s of rest between sets. Every four weeks the exercises will be changed. The progression will occur increasing the resistance of the springs and the level of difficulty of the exercises. Training intensity will be measured using Modified Borg's Perceived Effort Scale and then kept moderate throughout the program.
arm group label: Group control
arm group type: No Intervention
description: The subjects allocated in the control group will remain with their usual activities, and after the reevaluation will be offered the intervention that presents the greater size of effect.
intervention type: Other
intervention name: Pilates Method Exercises
description: Pilates Method exercises performed on the apparatus, on the ground and with accessories. They will always be performed by a physiotherapist with teaching certification in the Pilates methodology and will be supervised by two properly trained physiotherapy trainees. Participants will start the exercise program in small groups of up to 8 people, twice a week for 60 minutes, for 12 weeks, totaling 24 sessions. The first day of intervention for both groups will be devoted to explaining the six principles described by Joseph Pilates: centralization, concentration, control, precision, fluidity and breathing, and some fundamentals such as the neutral position of the spine. And in all sessions, these principles will be remembered by the physiotherapist.
arm group label: Pilates Method Exercises - higher volume
arm group label: Pilates Method Exercises - lower volume
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mônica D Caetano
role: Principal Investigator
affiliation: University of Brasilia
facility: 
country: Brazil
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PMID: 17671236
citation: Delmonico MJ, Harris TB, Lee JS, Visser M, Nevitt M, Kritchevsky SB, Tylavsky FA, Newman AB; Health, Aging and Body Composition Study. Alternative definitions of sarcopenia, lower extremity performance, and functional impairment with aging in older men and women. J Am Geriatr Soc. 2007 May;55(5):769-74. doi: 10.1111/j.1532-5415.2007.01140.x.
PMID: 17493199
citation: Estrada M, Kleppinger A, Judge JO, Walsh SJ, Kuchel GA. Functional impact of relative versus absolute sarcopenia in healthy older women. J Am Geriatr Soc. 2007 Nov;55(11):1712-9. doi: 10.1111/j.1532-5415.2007.01436.x.
PMID: 17979895
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PMID: 19026966
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PMID: 23723694
citation: Stathokostas L, McDonald MW, Little RM, Paterson DH. Flexibility of older adults aged 55-86 years and the influence of physical activity. J Aging Res. 2013;2013:743843. doi: 10.1155/2013/743843. Epub 2013 Jun 19.
PMID: 23862064
citation: de Oliveira Francisco C, de Almeida Fagundes A, Gorges B. Effects of Pilates method in elderly people: Systematic review of randomized controlled trials. J Bodyw Mov Ther. 2015 Jul;19(3):500-8. doi: 10.1016/j.jbmt.2015.03.003. Epub 2015 Mar 20.
PMID: 26118523
citation: Irez GB, Ozdemir RA, Evin R, Irez SG, Korkusuz F. Integrating pilates exercise into an exercise program for 65+ year-old women to reduce falls. J Sports Sci Med. 2011 Mar 1;10(1):105-11. eCollection 2011.
PMID: 24149302
citation: Bullo V, Bergamin M, Gobbo S, Sieverdes JC, Zaccaria M, Neunhaeuserer D, Ermolao A. The effects of Pilates exercise training on physical fitness and wellbeing in the elderly: A systematic review for future exercise prescription. Prev Med. 2015 Jun;75:1-11. doi: 10.1016/j.ypmed.2015.03.002. Epub 2015 Mar 12.
PMID: 25773473
citation: Siqueira Rodrigues BG, Ali Cader S, Bento Torres NV, Oliveira EM, Martin Dantas EH. Pilates method in personal autonomy, static balance and quality of life of elderly females. J Bodyw Mov Ther. 2010 Apr;14(2):195-202. doi: 10.1016/j.jbmt.2009.12.005. Epub 2010 Jan 29.
PMID: 20226367
citation: Mallery LH, MacDonald EA, Hubley-Kozey CL, Earl ME, Rockwood K, MacKnight C. The feasibility of performing resistance exercise with acutely ill hospitalized older adults. BMC Geriatr. 2003 Oct 7;3:3. doi: 10.1186/1471-2318-3-3.
PMID: 14531932
citation: Bergamin M, Gobbo S, Bullo V, Zanotto T, Vendramin B, Duregon F, Cugusi L, Camozzi V, Zaccaria M, Neunhaeuserer D, Ermolao A. Effects of a Pilates exercise program on muscle strength, postural control and body composition: results from a pilot study in a group of post-menopausal women. Age (Dordr). 2015 Dec;37(6):118. doi: 10.1007/s11357-015-9852-3. Epub 2015 Nov 15.
PMID: 26578458
citation: Markovic G, Sarabon N, Greblo Z, Krizanic V. Effects of feedback-based balance and core resistance training vs. Pilates training on balance and muscle function in older women: a randomized-controlled trial. Arch Gerontol Geriatr. 2015 Sep-Oct;61(2):117-23. doi: 10.1016/j.archger.2015.05.009. Epub 2015 May 27.
PMID: 26036209
citation: Oliveira LC, Pires-Oliveira DA, Abucarub AC, Oliveira LS, Oliveira RG. Pilates increases isokinetic muscular strength of the elbow flexor and extensor muscles of older women: A randomized controlled clinical trial. J Bodyw Mov Ther. 2017 Jan;21(1):2-10. doi: 10.1016/j.jbmt.2016.03.002. Epub 2016 Mar 10.
PMID: 28167180
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citation: Lord SR, Menz HB, Tiedemann A. A physiological profile approach to falls risk assessment and prevention. Phys Ther. 2003 Mar;83(3):237-52.
PMID: 12620088
citation: McCarthy EK, Horvat MA, Holtsberg PA, Wisenbaker JM. Repeated chair stands as a measure of lower limb strength in sexagenarian women. J Gerontol A Biol Sci Med Sci. 2004 Nov;59(11):1207-12. doi: 10.1093/gerona/59.11.1207.
PMID: 15602077
citation: Wells C, Kolt GS, Bialocerkowski A. Defining Pilates exercise: a systematic review. Complement Ther Med. 2012 Aug;20(4):253-62. doi: 10.1016/j.ctim.2012.02.005. Epub 2012 Mar 13.
PMID: 22579438
responsible party type: Principal Investigator
investigator affiliation: University of Brasilia
investigator full name: Mônica Batista Duarte Caetano
investigator title: Postgraduate Student of the Post-graduation Program in Rehabilitation Sciences da University de Brasilia
sharing ipd: No
provided document: 