Viewing Study NCT02984189



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Study NCT ID: NCT02984189
Status: UNKNOWN
Last Update Posted: 2016-12-06
First Post: 2016-11-29

Brief Title: Effect of Inspiratory Muscle Training on Recreational Cyclists
Sponsor: Universidade Federal de Sao Carlos
Organization: Universidade Federal de Sao Carlos

Study Overview

Official Title: Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists A Randomized Controlled Trial
Status: UNKNOWN
Status Verified Date: 2016-12
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IMT
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 ObjectiveTo 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 timeTLIM 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 835 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 timesweek 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 p005 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None