<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/NCT04491708</url>
  </required_header>
  <id_info>
    <org_study_id>28657514.0.0000.0029</org_study_id>
    <nct_id>NCT04491708</nct_id>
  </id_info>
  <brief_title>What is the Metabolic Intensity of Pilates</brief_title>
  <official_title>What is the Metabolic Intensity of Pilates: An Analysis of the Energy Expenditure and Cardiovascular Markers of Intensity of Apparatus and Mat Pilates Sessions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of Brasília</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of Brasília</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>
      Background: Pilates is a form of structured physical activity that is commonly used in&#xD;
      rehabilitation settings and to improve muscular fitness, balance, and flexibility. Despite&#xD;
      its popularity, it is not known whether the energy expenditure (EE) and oxygen consumption&#xD;
      from Pilates sessions could also lead to metabolic fitness benefits. The aim of this study&#xD;
      was to quantify the intensity and the EE during two different types of Pilates sessions (mat&#xD;
      and apparatus). Methods: 18 healthy females (age: 22 ± 3 years; height: 1.6 ± 0.1cm; body&#xD;
      mass: 61.0 ± 10.0 kg; body mass index: 21 ± 3 kg/cm2) performed two different sessions. Each&#xD;
      session involved the performance of 15 different exercises. Oxygen consumption (VO2) was&#xD;
      measured continuously and then converted to EE in Kcal/min. Blood lactate, heart rate (HR),&#xD;
      and blood pressure (BP) were also measured. A repeated measures two-way ANOVA (time X group)&#xD;
      determined differences between types.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants attended two half-hour Pilates exercise classes twice a week, for one month,&#xD;
      to familiarize themselves with the exercises and to learn the 5 Pilates' principles. After&#xD;
      the learning period, two experimental sessions were performed: a Mat Pilates session and a&#xD;
      Reformer apparatus Pilates session. The order of each session was randomized and drawn&#xD;
      beforehand. Each experimental session lasted about one and a half hours and the interval&#xD;
      between the sessions was 48 hours. Participants were asked to not perform any exercise and to&#xD;
      refrain from food or fluids except water eight hours prior to each experimental session.&#xD;
      Prior to the start of the experimental sessions, participants received a standard breakfast&#xD;
      of 321 kcal that was 76% (61 g) carbohydrate, 8% (6,7 g) protein, 16% (5,9) fat, provided by&#xD;
      the study researchers. All sessions were conducted at the same time in the morning, and the&#xD;
      room temperature (22°C) and humidity (40-50%) were controlled during the whole session.&#xD;
&#xD;
      Prior to the start of experimental sessions, participants rested in a supine position for 15&#xD;
      minutes. At the end of the 15 minutes, while still supine, measurements of BP and resting&#xD;
      blood lactate were taken using standard laboratory procedures. Participants were then&#xD;
      outfitted with a oxygen gas analyzer (Metalyzer 3b Cortex, Germany). Participants were&#xD;
      connected by a mask, covering mouth and nose, to a digital gas flow analyzer. Standard&#xD;
      calibration before every session was conducted according to the manufacturer's&#xD;
      instructions.VO2 and HR were then simultaneously recorded for 5 minutes in a sitting&#xD;
      position. At the end of the 5 minutes, the exercise session was started. VO2 and HR were&#xD;
      monitored continuously throughout the session, while BP was assessed during rest intervals&#xD;
      between exercises. At the end of the exercise session, BP and blood lactate were measured one&#xD;
      time in a supine position in the post recovery time period. VO2 and HR were measured&#xD;
      continuously for 5 minutes post session in a sitting position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2015</start_date>
  <completion_date type="Actual">January 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2015</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy expenditure</measure>
    <time_frame>50 minutes</time_frame>
    <description>VO2 was measured continuously for both Mat and Reformer apparatus Pilates as described previously. Data were calculated on breath-by-breath intervals at rest and during exercise. The absolute EE in kilocalories per minute was estimated using a constant value of 5.05 kcal.L-1 O2, so the O2 values expressed in L/min were multiplied by 5.05. VO2 values in ml/min/kg were also considered for the analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Lactate</measure>
    <time_frame>10 minutes</time_frame>
    <description>Capillary blood samples were collected from a fingertip before the first exercise and immediately after the last exercise of the Mat Pilates and Reformer apparatus experimental sessions. These samples were added into a 3mL eppendorf tube with sodium fluorite and this mixture was frozen to be further analyzed via spectrophotometry using a YSI 2300 STAT Plus (Yellow Springs Instrument, Yellow Springs, Ohio, USA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>50 minutes</time_frame>
    <description>HR was recorded continuously throughout the sessions using a POLAR RS800cx heart-rate monitor (Polar Electro, Kempele, Finland) as per manufacturers guidelines for sensor belt placement. The mean HR of each Pilates sessions was determined using the Polar Precision Performance software (version 5.40.172).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>15 minutes</time_frame>
    <description>BP was measured using a digital BP monitor (Microlife BP 3BTO-A, São Paulo, Brazil) on the left arm. BP was measured, when participants lied on a bed on supine position, before, during (in the rest intervals between exercises) and after the exercises in the post exercise. Both pressures, sistolic and diastolic, was assessed during the study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Energy Expenditure</condition>
  <arm_group>
    <arm_group_label>Apparatus Pilates</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The same Pilates exercises were performed during the Mat Pilates and Reformer apparatus sessions. For each exercise, one set of 10 repetitions was performed. Between each exercise, participants were allowed to rest for 2 minutes in a lying position. For each exercise in the Reformer apparatus, the number of springs used was defined during the familiarization sessions as the highest number of springs the participant could perform the 10 repetitions of the exercise with proper technique and following the 5 Pilates principles correctly. The exercises performed were (Stott 2003; Stott 2001): 1) Cat stretch; 2) Hip rolls; 3) Ab prep; 4) Breast stroke preps; 5) Hundred; 6) Breast stroke; 7) Half roll back; 8) Single leg stretch; 9) Slow double leg stretch; 10) Double leg stretch; 11) Double leg circle; 12) Scissors; 13) Roll over; 14) Teaser; 15) Spine stretch forward.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mat Pilates</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The same Pilates exercises were performed during the Mat Pilates and Reformer apparatus sessions. For each exercise, one set of 10 repetitions was performed. Between each exercise, participants were allowed to rest for 2 minutes in a lying position. For each exercise in the Reformer apparatus, the number of springs used was defined during the familiarization sessions as the highest number of springs the participant could perform the 10 repetitions of the exercise with proper technique and following the 5 Pilates principles correctly. The exercises performed were (Stott 2003; Stott 2001): 1) Cat stretch; 2) Hip rolls; 3) Ab prep; 4) Breast stroke preps; 5) Hundred; 6) Breast stroke; 7) Half roll back; 8) Single leg stretch; 9) Slow double leg stretch; 10) Double leg stretch; 11) Double leg circle; 12) Scissors; 13) Roll over; 14) Teaser; 15) Spine stretch forward.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pilates exercises</intervention_name>
    <description>The participants attended two half-hour Pilates exercise classes twice a week, for one month, to familiarize themselves with the exercises and to learn the 5 Pilates' principles. After the learning period, two experimental sessions were performed: a Mat Pilates session and a Reformer apparatus Pilates session. The order of each session was randomized and drawn beforehand. Each experimental session lasted about one and a half hours and the interval between the sessions was 48 hours. Participants were asked to not perform any exercise and to refrain from food or fluids except water eight hours prior to each experimental session. Prior to the start of the experimental sessions, participants received a standard breakfast of 321 kcal that was 76% (61 g) carbohydrate, 8% (6,7 g) protein, 16% (5,9) fat, provided by the study researchers. All sessions were conducted at the same time in the morning, and the room temperature (22°C) and humidity (40-50%) were controlled during the whole session.</description>
    <arm_group_label>Apparatus Pilates</arm_group_label>
    <arm_group_label>Mat Pilates</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged up to 30 years;&#xD;
&#xD;
          -  Sedentary or irregularly active, as assessed by the International Physical Activity&#xD;
             Questionnaire (IPAQ);&#xD;
&#xD;
          -  Not have any prior experience in Pilates exercises.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have any clinical or orthopedic conditions/disease;&#xD;
&#xD;
          -  Practitioner of any type of exercise.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yomara Mota</last_name>
    <role>Study Director</role>
    <affiliation>Catholic University of Brasilia</affiliation>
  </overall_official>
  <reference>
    <citation>Wilmore JH, Parr RB, Ward P, Vodak PA, Barstow TJ, Pipes TV, Grimditch G, Leslie P. Energy cost of circuit weight training. Med Sci Sports. 1978 Summer;10(2):75-8.</citation>
    <PMID>692305</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of Brasília</investigator_affiliation>
    <investigator_full_name>Letícia de Souza Andrade</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04491708
org study id: 28657514.0.0000.0029
nct id: NCT04491708
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background: Pilates is a form of structured physical activity that is commonly used in
      rehabilitation settings and to improve muscular fitness, balance, and flexibility. Despite
      its popularity, it is not known whether the energy expenditure (EE) and oxygen consumption
      from Pilates sessions could also lead to metabolic fitness benefits. The aim of this study
      was to quantify the intensity and the EE during two different types of Pilates sessions (mat
      and apparatus). Methods: 18 healthy females (age: 22 ± 3 years; height: 1.6 ± 0.1cm; body
      mass: 61.0 ± 10.0 kg; body mass index: 21 ± 3 kg/cm2) performed two different sessions. Each
      session involved the performance of 15 different exercises. Oxygen consumption (VO2) was
      measured continuously and then converted to EE in Kcal/min. Blood lactate, heart rate (HR),
      and blood pressure (BP) were also measured. A repeated measures two-way ANOVA (time X group)
      determined differences between types.
The participants attended two half-hour Pilates exercise classes twice a week, for one month,
      to familiarize themselves with the exercises and to learn the 5 Pilates' principles. After
      the learning period, two experimental sessions were performed: a Mat Pilates session and a
      Reformer apparatus Pilates session. The order of each session was randomized and drawn
      beforehand. Each experimental session lasted about one and a half hours and the interval
      between the sessions was 48 hours. Participants were asked to not perform any exercise and to
      refrain from food or fluids except water eight hours prior to each experimental session.
      Prior to the start of the experimental sessions, participants received a standard breakfast
      of 321 kcal that was 76% (61 g) carbohydrate, 8% (6,7 g) protein, 16% (5,9) fat, provided by
      the study researchers. All sessions were conducted at the same time in the morning, and the
      room temperature (22°C) and humidity (40-50%) were controlled during the whole session.

      Prior to the start of experimental sessions, participants rested in a supine position for 15
      minutes. At the end of the 15 minutes, while still supine, measurements of BP and resting
      blood lactate were taken using standard laboratory procedures. Participants were then
      outfitted with a oxygen gas analyzer (Metalyzer 3b Cortex, Germany). Participants were
      connected by a mask, covering mouth and nose, to a digital gas flow analyzer. Standard
      calibration before every session was conducted according to the manufacturer's
      instructions.VO2 and HR were then simultaneously recorded for 5 minutes in a sitting
      position. At the end of the 5 minutes, the exercise session was started. VO2 and HR were
      monitored continuously throughout the session, while BP was assessed during rest intervals
      between exercises. At the end of the exercise session, BP and blood lactate were measured one
      time in a supine position in the post recovery time period. VO2 and HR were measured
      continuously for 5 minutes post session in a sitting position.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Energy expenditure
time frame: 50 minutes
description: VO2 was measured continuously for both Mat and Reformer apparatus Pilates as described previously. Data were calculated on breath-by-breath intervals at rest and during exercise. The absolute EE in kilocalories per minute was estimated using a constant value of 5.05 kcal.L-1 O2, so the O2 values expressed in L/min were multiplied by 5.05. VO2 values in ml/min/kg were also considered for the analysis.
measure: Blood Lactate
time frame: 10 minutes
description: Capillary blood samples were collected from a fingertip before the first exercise and immediately after the last exercise of the Mat Pilates and Reformer apparatus experimental sessions. These samples were added into a 3mL eppendorf tube with sodium fluorite and this mixture was frozen to be further analyzed via spectrophotometry using a YSI 2300 STAT Plus (Yellow Springs Instrument, Yellow Springs, Ohio, USA).
measure: Heart rate
time frame: 50 minutes
description: HR was recorded continuously throughout the sessions using a POLAR RS800cx heart-rate monitor (Polar Electro, Kempele, Finland) as per manufacturers guidelines for sensor belt placement. The mean HR of each Pilates sessions was determined using the Polar Precision Performance software (version 5.40.172).
measure: Blood pressure
time frame: 15 minutes
description: BP was measured using a digital BP monitor (Microlife BP 3BTO-A, São Paulo, Brazil) on the left arm. BP was measured, when participants lied on a bed on supine position, before, during (in the rest intervals between exercises) and after the exercises in the post exercise. Both pressures, sistolic and diastolic, was assessed during the study period.
arm group label: Apparatus Pilates
arm group type: Experimental
description: The same Pilates exercises were performed during the Mat Pilates and Reformer apparatus sessions. For each exercise, one set of 10 repetitions was performed. Between each exercise, participants were allowed to rest for 2 minutes in a lying position. For each exercise in the Reformer apparatus, the number of springs used was defined during the familiarization sessions as the highest number of springs the participant could perform the 10 repetitions of the exercise with proper technique and following the 5 Pilates principles correctly. The exercises performed were (Stott 2003; Stott 2001): 1) Cat stretch; 2) Hip rolls; 3) Ab prep; 4) Breast stroke preps; 5) Hundred; 6) Breast stroke; 7) Half roll back; 8) Single leg stretch; 9) Slow double leg stretch; 10) Double leg stretch; 11) Double leg circle; 12) Scissors; 13) Roll over; 14) Teaser; 15) Spine stretch forward.
arm group label: Mat Pilates
arm group type: Experimental
description: The same Pilates exercises were performed during the Mat Pilates and Reformer apparatus sessions. For each exercise, one set of 10 repetitions was performed. Between each exercise, participants were allowed to rest for 2 minutes in a lying position. For each exercise in the Reformer apparatus, the number of springs used was defined during the familiarization sessions as the highest number of springs the participant could perform the 10 repetitions of the exercise with proper technique and following the 5 Pilates principles correctly. The exercises performed were (Stott 2003; Stott 2001): 1) Cat stretch; 2) Hip rolls; 3) Ab prep; 4) Breast stroke preps; 5) Hundred; 6) Breast stroke; 7) Half roll back; 8) Single leg stretch; 9) Slow double leg stretch; 10) Double leg stretch; 11) Double leg circle; 12) Scissors; 13) Roll over; 14) Teaser; 15) Spine stretch forward.
intervention type: Other
intervention name: Pilates exercises
description: The participants attended two half-hour Pilates exercise classes twice a week, for one month, to familiarize themselves with the exercises and to learn the 5 Pilates' principles. After the learning period, two experimental sessions were performed: a Mat Pilates session and a Reformer apparatus Pilates session. The order of each session was randomized and drawn beforehand. Each experimental session lasted about one and a half hours and the interval between the sessions was 48 hours. Participants were asked to not perform any exercise and to refrain from food or fluids except water eight hours prior to each experimental session. Prior to the start of the experimental sessions, participants received a standard breakfast of 321 kcal that was 76% (61 g) carbohydrate, 8% (6,7 g) protein, 16% (5,9) fat, provided by the study researchers. All sessions were conducted at the same time in the morning, and the room temperature (22°C) and humidity (40-50%) were controlled during the whole session.
arm group label: Apparatus Pilates
arm group label: Mat Pilates
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yomara Mota
role: Study Director
affiliation: Catholic University of Brasilia
citation: Wilmore JH, Parr RB, Ward P, Vodak PA, Barstow TJ, Pipes TV, Grimditch G, Leslie P. Energy cost of circuit weight training. Med Sci Sports. 1978 Summer;10(2):75-8.
PMID: 692305
responsible party type: Principal Investigator
investigator affiliation: Catholic University of Brasília
investigator full name: Letícia de Souza Andrade
investigator title: Clinical Professor
sharing ipd: No