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Trial record 5 of 11 for:    21694556 [PUBMED-IDS]

Effect of Inspiratory Muscle Training on Recreational Cyclists (IMT)

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ClinicalTrials.gov Identifier: NCT02984189
Recruitment Status : Unknown
Verified December 2016 by Aparecida Maria Catai, Universidade Federal de Sao Carlos.
Recruitment status was:  Recruiting
First Posted : December 6, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Aparecida Maria Catai, Universidade Federal de Sao Carlos

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Inspiratory muscle training Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists: A Randomized Controlled Trial
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Experimental: Inspiratory Critical Pressure Group
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.
Other: Inspiratory muscle training
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).

Active Comparator: 60% Maximal Inspiratory Pressure Group
60% of maximal inspiratory pressure will be used for training.
Other: Inspiratory muscle training
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).

Sham Comparator: Sham Group
6 cmH20 will be used for training.
Other: Inspiratory muscle training
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).




Primary Outcome Measures :
  1. Performance in exercise evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak) [ Time Frame: Three years ]
    The performance will be evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak), determinated by the cardiopulmonary exercise testing.

  2. Performance in exercise evaluated by measurement the work load (W) [ Time Frame: Three years ]

    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.



Secondary Outcome Measures :
  1. Cardiovascular responses to inspiratory muscle training [ Time Frame: Three years ]

    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.


  2. Respiratory responses to inspiratory muscle training [ Time Frame: Three years ]

    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.


  3. Metabolic responses to inspiratory muscle training [ Time Frame: Three years ]

    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.


  4. Autonomic responses to inspiratory muscle training [ Time Frame: Three years ]

    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.


  5. Metaboreflex activation to inspiratory muscle training [ Time Frame: Three years ]

    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.




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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apparently Healthy;
  • Practicing cycling for at least 6 months continuous and at least 150 min weekly as active [by the American College of Sports Medicine (2011)].

Exclusion Criteria:

  • Participants can not be: smokers, alcoholics, illegal drug users or drugs that may interfere in the search results;
  • Diagnosis of cardiorespiratory and metabolic disease;
  • Absence of ischemic and conduction ECG alterations at rest or during the clinical exercise test;
  • Body mass index (BMI) <30 kg/m²;
  • Presence of respiratory muscle weakness [maximal inspiratory pressure (MIP <60% predicted);
  • Alterations in the pulmonary function test (PFT) or other test;
  • Have performed of inspiratory muscle training in the last six months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984189


Contacts
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Contact: Patricia Rehder-Santos, Master +55 19 98118-4926 rehderpaty@hotmail.com

Locations
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Brazil
Federal University of Sao Carlos Recruiting
Sao Carlos, Sao Paulo, Brazil, 676, 13565-905
Contact: Patricia Rehder-Santos, MSc    +55 19 98118 4926    rehderpaty@hotmail.com   
Contact: Aparecida M Catai, Professor    +55 16 3351 8705    rehderpaty@gmail.com   
Sub-Investigator: Raphael M Abreu         
Sub-Investigator: Étore F Signini         
Sub-Investigator: Camila A Sagaguchi, MSc         
Principal Investigator: Aparecida M Catai, Professor         
Sub-Investigator: Patricia Rehder-Santos, MSc         
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Investigators
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Principal Investigator: Aparecida M Catai, PhD Universidade Federal de Sao Carlos

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aparecida Maria Catai, Professor Aparecida Maria Catai, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT02984189     History of Changes
Other Study ID Numbers: 55990116.0.0000.5504
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aparecida Maria Catai, Universidade Federal de Sao Carlos:
Physical Exercise
Physical Therapy
Physical Performance
Critical Power
Respiratory Muscle
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes