<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/NCT02984189</url>
  </required_header>
  <id_info>
    <org_study_id>55990116.0.0000.5504</org_study_id>
    <nct_id>NCT02984189</nct_id>
  </id_info>
  <brief_title>Effect of Inspiratory Muscle Training on Recreational Cyclists</brief_title>
  <acronym>IMT</acronym>
  <official_title>Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Sao Carlos</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Sao Carlos</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: The inspiratory muscle training (IMT) has showed great benefits to the&#xD;
      respiratory, autonomic system, and mainly to the improvement of physical performance in&#xD;
      healthy subjects. The latter is related to the improvement of respiratory muscle strength,&#xD;
      decreased of dyspnoea, peripheral fatigue and delay in activation of muscle metaboreflex&#xD;
      during exercise. However, there is no consensus about the best training load to IMT, because&#xD;
      the prescription has been done only using percentage of the maximal inspiratory pressure&#xD;
      (MIP), and 60% of MIP has been the most used. Therefore, the IMT prescription protocol that&#xD;
      takes into account the respiratory muscle strength and endurance can provide additional&#xD;
      benefits to protocols commonly applied, once that respiratory muscle differs from the other&#xD;
      muscles due to its greater muscle endurance. In the sense, the IMT using inspiratory critical&#xD;
      pressure (PThC) comes up with an alternative, since the PThC calculation considers these&#xD;
      characteristics. Objective:To evaluate the effect of the IMT, using PThC, on cardiovascular,&#xD;
      respiratory, metabolic and autonomic responses in recreational cyclists and compare it to a&#xD;
      IMT using 60% of MIP. Methods: Thirty men recreational cyclists (20-40 years), will be&#xD;
      randomized to placebo group (PG, n = 10), PThC group (PTHCG, n = 10) and 60% of MIP group&#xD;
      (60G, n = 10), taking into account the age and functional aerobic capacity. All subjects will&#xD;
      perform the following evaluations: cardiovascular autonomic tests [heart rate variability&#xD;
      (HRV) and blood pressure variability (BPV) at rest and after active postural change],&#xD;
      pulmonary function testing, respiratory muscle strength (RMS) test, cardiopulmonary exercise&#xD;
      testing (CPET), incremental respiratory muscle endurance test (iRME) [maximum respiratory&#xD;
      pressure sustained for 1 minute (PThMAX)] and constant respiratory loads test (95%, 100% and&#xD;
      105% of PThMAX), both using an linear inspiratory load resistor (PowerBreathe K5). The PThC&#xD;
      will be obtained from the linear regression using the time(TLIM) of and load of each constant&#xD;
      test (95%, 100% and 105% PThMAX). During evaluations, the ECG (BioAmp FE132), blood pressure&#xD;
      (BP), using Finometer Pro (Finapress Medical Systems) and respiration (Marazza) signals will&#xD;
      be acquired. The signals will be coupled by data acquisition and analysis device (Power Lab&#xD;
      8/35) and sampled at 1000 Hz. Moreover, the oxyhemoglobin, deoxyhemoglobin and total&#xD;
      hemoglobin responses will be measured by near-infrared spectroscopy (NIRS) (Oxymon MKIII),&#xD;
      sampled at 250Hz. The IMT will be performed for 11 weeks (3 times/week, 1-hour duration). The&#xD;
      session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes&#xD;
      (breathing against 100% of the training load) with 1-min interval between them. Heart rate&#xD;
      and BP will be monitored in all training sessions. The RMS, iRME, respiratory constant load&#xD;
      tests and CPET will be performed before and after the training, and in the 3rd and 7th week&#xD;
      (for training load adjustment). The pulmonary function testing and the cardiovascular&#xD;
      autonomic tests will be performed only before and after training. The data will be analyzed&#xD;
      by specific statistical tests (parametric and nonparametric) according to the data&#xD;
      distribution and their respective variances. Significance will be set at p&lt;0.05. Expected&#xD;
      results: It is expected that the training performed by PTHCG, when compared to training&#xD;
      performed by 60G and PG, promotes: greater improvementin workload (Watts) and peak oxygen&#xD;
      uptake (VO2peak); increasing in MIP and iRME; decreasing of dyspnoea and peripheral fatigue;&#xD;
      delay in activation of muscle metaboreflex in the CPET and iRME; improvement incardiac&#xD;
      parasympathetic autonomic modulation and reducing cardiac and peripheral sympathetic&#xD;
      modulation. Moreover, it is expected that the results can provide information for a better&#xD;
      understanding of the responses obtained by the PThC training in the different evaluated&#xD;
      systems. In addition, these results will allow the use of this method by health professionals&#xD;
      as a new assessment tool and IMT prescription.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance in exercise evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak)</measure>
    <time_frame>Three years</time_frame>
    <description>The performance will be evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak), determinated by the cardiopulmonary exercise testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance in exercise evaluated by measurement the work load (W)</measure>
    <time_frame>Three years</time_frame>
    <description>The performance will be evaluated by measurement the work load (W), determinated by the cardiopulmonary exercise testing.&#xD;
The evaluation will realize before, fifth and ninth weeks and after the training.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular responses to inspiratory muscle training</measure>
    <time_frame>Three years</time_frame>
    <description>The cardiovascular responses [systolic arterial pressure (PAS), dyastolic arterial pressure (PAD), using Finometer PRO; and heart rate, using BioAmp FE132] will be evaluated during the cardiopulmonary exercise testing and progressive inspiratory threshold-loading test, .&#xD;
The evaluation will realize before, fifth and ninth weeks and after the training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory responses to inspiratory muscle training</measure>
    <time_frame>Three years</time_frame>
    <description>The ventilatory parameters [carbon dioxide production (VCO₂), respiratory exchange rate (RER), lung ventilation (VE), oxygen uptake efficiency slope (OUES), minute ventilation-carbon dioxide production slope (VE/VCO₂slope)] will monitored and registered breath-by-breath using a ventilatory-metabolic system ULTIMA/Breeze Suite 7.2., during cardiopulmonary exercise test and progressive inspiratory threshold-loading test.&#xD;
The evaluation will realize before, fifth and ninth weeks and after the training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic responses to inspiratory muscle training</measure>
    <time_frame>Three years</time_frame>
    <description>The oxyhemoglobin, deoxyhemoglobin and total hemoglobin responses will be measured by near-infrared spectroscopy (NIRS) (Oxymon MKIII), during cardiopulmonary exercise test and progressive inspiratory threshold-loading test.&#xD;
The evaluation will realize before, fifth and ninth weeks and after the training.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autonomic responses to inspiratory muscle training</measure>
    <time_frame>Three years</time_frame>
    <description>The cardiovascular autonomic tests, heart rate variability (HRV) and blood pressure variability (BPV), at rest and after active postural change will realize before and after the training.&#xD;
The ECG (BioAmp FE132), blood pressure (BP), using Finometer Pro (Finapress Medical Systems) and respiration (Marazza) signals will be acquired. The signals will be coupled by data acquisition and analysis device (Power Lab 8/35) and sampled at 1000 Hz.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metaboreflex activation to inspiratory muscle training</measure>
    <time_frame>Three years</time_frame>
    <description>To evaluate if the IMT, using PThC, changes the intensity of the metaboreflex activation, evaluated during the cardiopulmonary exercise testing and the progressive inspiratory threshold-loading test.&#xD;
The evaluation will realize before, fifth and ninth weeks and after the training.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Inspiratory Critical Pressure Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inspiratory Critical Pressure will be used for training and will be determined, from a progressive inspiratory threshold-loading test will start with 50%MIP followed by 10%MIP increments, every 3min until subjects reached a load that there were unable to sustain for at least 1min (PThMAX). On another day, the subjects will perform a constant inspiratory loading test against a resistance of 95%, 100% and 105%PThMAX, for as long as they could tolerate. The intensity loads will be applied according the results of block randomization. The time elapsed until task failure was defined as inspiratory muscle endurance time, and will use to set the PThC. The respiratory work done (inspiratory pressure values) will be plotted in abscissa and the time-to-exhaustion in ordinate, and a linear regression going through the 3 points will be applied using the pressure-1/t relationship. The slope of the parallel line displaced downward projecting to the origin produce the PThC value.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>60% Maximal Inspiratory Pressure Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>60% of maximal inspiratory pressure will be used for training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>6 cmH20 will be used for training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inspiratory muscle training</intervention_name>
    <description>The inspiratory muscle training (IMT) will be realized, to compare three intensities differents the training (Inspiratory critical pressure, 60% maximal inspiratory pressure and sham). The IMT will be performed for 11 weeks (33 sessions, 3 times/week, 1-hour duration). The session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes (breathing against 100% of the training load) with 1-min interval between them, using a linear inspiratory load resistor (Device: PowerBreathe K5).</description>
    <arm_group_label>60% Maximal Inspiratory Pressure Group</arm_group_label>
    <arm_group_label>Inspiratory Critical Pressure Group</arm_group_label>
    <arm_group_label>Sham Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently Healthy;&#xD;
&#xD;
          -  Practicing cycling for at least 6 months continuous and at least 150 min weekly as&#xD;
             active [by the American College of Sports Medicine (2011)].&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants can not be: smokers, alcoholics, illegal drug users or drugs that may&#xD;
             interfere in the search results;&#xD;
&#xD;
          -  Diagnosis of cardiorespiratory and metabolic disease;&#xD;
&#xD;
          -  Absence of ischemic and conduction ECG alterations at rest or during the clinical&#xD;
             exercise test;&#xD;
&#xD;
          -  Body mass index (BMI) &lt;30 kg/m²;&#xD;
&#xD;
          -  Presence of respiratory muscle weakness [maximal inspiratory pressure (MIP &lt;60%&#xD;
             predicted);&#xD;
&#xD;
          -  Alterations in the pulmonary function test (PFT) or other test;&#xD;
&#xD;
          -  Have performed of inspiratory muscle training in the last six months.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aparecida M Catai, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal de Sao Carlos</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patricia Rehder-Santos, Master</last_name>
    <phone>+55 19 98118-4926</phone>
    <email>rehderpaty@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal University of Sao Carlos</name>
      <address>
        <city>Sao Carlos</city>
        <state>Sao Paulo</state>
        <zip>676, 13565-905</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patricia Rehder-Santos, MSc</last_name>
      <phone>+55 19 98118 4926</phone>
      <email>rehderpaty@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Aparecida M Catai, Professor</last_name>
      <phone>+55 16 3351 8705</phone>
      <email>rehderpaty@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Raphael M Abreu</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Étore F Signini</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Camila A Sagaguchi, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aparecida M Catai, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Patricia Rehder-Santos, MSc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.</citation>
    <PMID>12186831</PMID>
  </reference>
  <reference>
    <citation>Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.</citation>
    <PMID>21694556</PMID>
  </reference>
  <reference>
    <citation>Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.</citation>
    <PMID>20585013</PMID>
  </reference>
  <reference>
    <citation>Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.</citation>
    <PMID>7154893</PMID>
  </reference>
  <reference>
    <citation>HajGhanbari B, Yamabayashi C, Buna TR, Coelho JD, Freedman KD, Morton TA, Palmer SA, Toy MA, Walsh C, Sheel AW, Reid WD. Effects of respiratory muscle training on performance in athletes: a systematic review with meta-analyses. J Strength Cond Res. 2013 Jun;27(6):1643-63. doi: 10.1519/JSC.0b013e318269f73f.</citation>
    <PMID>22836606</PMID>
  </reference>
  <reference>
    <citation>Hautmann H, Hefele S, Schotten K, Huber RM. Maximal inspiratory mouth pressures (PIMAX) in healthy subjects--what is the lower limit of normal? Respir Med. 2000 Jul;94(7):689-93. doi: 10.1053/rmed.2000.0802.</citation>
    <PMID>10926341</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Sao Carlos</investigator_affiliation>
    <investigator_full_name>Aparecida Maria Catai</investigator_full_name>
    <investigator_title>Professor Aparecida Maria Catai</investigator_title>
  </responsible_party>
  <keyword>Physical Exercise</keyword>
  <keyword>Physical Therapy</keyword>
  <keyword>Physical Performance</keyword>
  <keyword>Critical Power</keyword>
  <keyword>Respiratory Muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <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/NCT02984189
org study id: 55990116.0.0000.5504
nct id: NCT02984189
lead sponsor: 
has dmc: No
Introduction: The inspiratory muscle training (IMT) has showed great benefits to the
      respiratory, autonomic system, and mainly to the improvement of physical performance in
      healthy subjects. The latter is related to the improvement of respiratory muscle strength,
      decreased of dyspnoea, peripheral fatigue and delay in activation of muscle metaboreflex
      during exercise. However, there is no consensus about the best training load to IMT, because
      the prescription has been done only using percentage of the maximal inspiratory pressure
      (MIP), and 60% of MIP has been the most used. Therefore, the IMT prescription protocol that
      takes into account the respiratory muscle strength and endurance can provide additional
      benefits to protocols commonly applied, once that respiratory muscle differs from the other
      muscles due to its greater muscle endurance. In the sense, the IMT using inspiratory critical
      pressure (PThC) comes up with an alternative, since the PThC calculation considers these
      characteristics. Objective:To evaluate the effect of the IMT, using PThC, on cardiovascular,
      respiratory, metabolic and autonomic responses in recreational cyclists and compare it to a
      IMT using 60% of MIP. Methods: Thirty men recreational cyclists (20-40 years), will be
      randomized to placebo group (PG, n = 10), PThC group (PTHCG, n = 10) and 60% of MIP group
      (60G, n = 10), taking into account the age and functional aerobic capacity. All subjects will
      perform the following evaluations: cardiovascular autonomic tests [heart rate variability
      (HRV) and blood pressure variability (BPV) at rest and after active postural change],
      pulmonary function testing, respiratory muscle strength (RMS) test, cardiopulmonary exercise
      testing (CPET), incremental respiratory muscle endurance test (iRME) [maximum respiratory
      pressure sustained for 1 minute (PThMAX)] and constant respiratory loads test (95%, 100% and
      105% of PThMAX), both using an linear inspiratory load resistor (PowerBreathe K5). The PThC
      will be obtained from the linear regression using the time(TLIM) of and load of each constant
      test (95%, 100% and 105% PThMAX). During evaluations, the ECG (BioAmp FE132), blood pressure
      (BP), using Finometer Pro (Finapress Medical Systems) and respiration (Marazza) signals will
      be acquired. The signals will be coupled by data acquisition and analysis device (Power Lab
      8/35) and sampled at 1000 Hz. Moreover, the oxyhemoglobin, deoxyhemoglobin and total
      hemoglobin responses will be measured by near-infrared spectroscopy (NIRS) (Oxymon MKIII),
      sampled at 250Hz. The IMT will be performed for 11 weeks (3 times/week, 1-hour duration). The
      session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes
      (breathing against 100% of the training load) with 1-min interval between them. Heart rate
      and BP will be monitored in all training sessions. The RMS, iRME, respiratory constant load
      tests and CPET will be performed before and after the training, and in the 3rd and 7th week
      (for training load adjustment). The pulmonary function testing and the cardiovascular
      autonomic tests will be performed only before and after training. The data will be analyzed
      by specific statistical tests (parametric and nonparametric) according to the data
      distribution and their respective variances. Significance will be set at p<0.05. Expected
      results: It is expected that the training performed by PTHCG, when compared to training
      performed by 60G and PG, promotes: greater improvementin workload (Watts) and peak oxygen
      uptake (VO2peak); increasing in MIP and iRME; decreasing of dyspnoea and peripheral fatigue;
      delay in activation of muscle metaboreflex in the CPET and iRME; improvement incardiac
      parasympathetic autonomic modulation and reducing cardiac and peripheral sympathetic
      modulation. Moreover, it is expected that the results can provide information for a better
      understanding of the responses obtained by the PThC training in the different evaluated
      systems. In addition, these results will allow the use of this method by health professionals
      as a new assessment tool and IMT prescription.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Performance in exercise evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak)
time frame: Three years
description: The performance will be evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak), determinated by the cardiopulmonary exercise testing.
measure: Performance in exercise evaluated by measurement the work load (W)
time frame: Three years
description: The performance will be evaluated by measurement the work load (W), determinated by the cardiopulmonary exercise testing.
The evaluation will realize before, fifth and ninth weeks and after the training.
measure: Cardiovascular responses to inspiratory muscle training
time frame: Three years
description: The cardiovascular responses [systolic arterial pressure (PAS), dyastolic arterial pressure (PAD), using Finometer PRO; and heart rate, using BioAmp FE132] will be evaluated during the cardiopulmonary exercise testing and progressive inspiratory threshold-loading test, .
The evaluation will realize before, fifth and ninth weeks and after the training.
measure: Respiratory responses to inspiratory muscle training
time frame: Three years
description: The ventilatory parameters [carbon dioxide production (VCO₂), respiratory exchange rate (RER), lung ventilation (VE), oxygen uptake efficiency slope (OUES), minute ventilation-carbon dioxide production slope (VE/VCO₂slope)] will monitored and registered breath-by-breath using a ventilatory-metabolic system ULTIMA/Breeze Suite 7.2., during cardiopulmonary exercise test and progressive inspiratory threshold-loading test.
The evaluation will realize before, fifth and ninth weeks and after the training.
measure: Metabolic responses to inspiratory muscle training
time frame: Three years
description: The oxyhemoglobin, deoxyhemoglobin and total hemoglobin responses will be measured by near-infrared spectroscopy (NIRS) (Oxymon MKIII), during cardiopulmonary exercise test and progressive inspiratory threshold-loading test.
The evaluation will realize before, fifth and ninth weeks and after the training.
measure: Autonomic responses to inspiratory muscle training
time frame: Three years
description: The cardiovascular autonomic tests, heart rate variability (HRV) and blood pressure variability (BPV), at rest and after active postural change will realize before and after the training.
The ECG (BioAmp FE132), blood pressure (BP), using Finometer Pro (Finapress Medical Systems) and respiration (Marazza) signals will be acquired. The signals will be coupled by data acquisition and analysis device (Power Lab 8/35) and sampled at 1000 Hz.
measure: Metaboreflex activation to inspiratory muscle training
time frame: Three years
description: To evaluate if the IMT, using PThC, changes the intensity of the metaboreflex activation, evaluated during the cardiopulmonary exercise testing and the progressive inspiratory threshold-loading test.
The evaluation will realize before, fifth and ninth weeks and after the training.
arm group label: Inspiratory Critical Pressure Group
arm group type: Experimental
description: Inspiratory Critical Pressure will be used for training and will be determined, from a progressive inspiratory threshold-loading test will start with 50%MIP followed by 10%MIP increments, every 3min until subjects reached a load that there were unable to sustain for at least 1min (PThMAX). On another day, the subjects will perform a constant inspiratory loading test against a resistance of 95%, 100% and 105%PThMAX, for as long as they could tolerate. The intensity loads will be applied according the results of block randomization. The time elapsed until task failure was defined as inspiratory muscle endurance time, and will use to set the PThC. The respiratory work done (inspiratory pressure values) will be plotted in abscissa and the time-to-exhaustion in ordinate, and a linear regression going through the 3 points will be applied using the pressure-1/t relationship. The slope of the parallel line displaced downward projecting to the origin produce the PThC value.
arm group label: 60% Maximal Inspiratory Pressure Group
arm group type: Active Comparator
description: 60% of maximal inspiratory pressure will be used for training.
arm group label: Sham Group
arm group type: Sham Comparator
description: 6 cmH20 will be used for training.
intervention type: Other
intervention name: Inspiratory muscle training
description: The inspiratory muscle training (IMT) will be realized, to compare three intensities differents the training (Inspiratory critical pressure, 60% maximal inspiratory pressure and sham). The IMT will be performed for 11 weeks (33 sessions, 3 times/week, 1-hour duration). The session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes (breathing against 100% of the training load) with 1-min interval between them, using a linear inspiratory load resistor (Device: PowerBreathe K5).
arm group label: 60% Maximal Inspiratory Pressure Group
arm group label: Inspiratory Critical Pressure Group
arm group label: Sham Group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aparecida M Catai, PhD
role: Principal Investigator
affiliation: Universidade Federal de Sao Carlos
last name: Patricia Rehder-Santos, Master
phone: +55 19 98118-4926
email: rehderpaty@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Brazil
citation: American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PMID: 12186831
citation: Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PMID: 21694556
citation: Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.
PMID: 20585013
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PMID: 7154893
citation: HajGhanbari B, Yamabayashi C, Buna TR, Coelho JD, Freedman KD, Morton TA, Palmer SA, Toy MA, Walsh C, Sheel AW, Reid WD. Effects of respiratory muscle training on performance in athletes: a systematic review with meta-analyses. J Strength Cond Res. 2013 Jun;27(6):1643-63. doi: 10.1519/JSC.0b013e318269f73f.
PMID: 22836606
citation: Hautmann H, Hefele S, Schotten K, Huber RM. Maximal inspiratory mouth pressures (PIMAX) in healthy subjects--what is the lower limit of normal? Respir Med. 2000 Jul;94(7):689-93. doi: 10.1053/rmed.2000.0802.
PMID: 10926341
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Sao Carlos
investigator full name: Aparecida Maria Catai
investigator title: Professor Aparecida Maria Catai
mesh term: Respiratory Aspiration
sharing ipd: No