Effect of Inspiratory Muscle Training on Recreational Cyclists

Healthy Clinical Trial

— IMT  

Official title:

Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02984189
• Other study ID #: 55990116.0.0000.5504
• Status: Recruiting
• Phase: Phase 2
• First received: November 29, 2016
• Last updated: December 1, 2016
• Start date: February 2016
• Est. completion date: February 2019

Study information

• Verified date: December 2016
• Source: Universidade Federal de Sao Carlos
• Contact: Patricia Rehder-Santos, Master
• Phone: +55 19 98118-4926
• Email: rehderpaty[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

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).

Locations

Country	Name	City	State
Brazil	Federal University of Sao Carlos	Sao Carlos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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. — View 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. Review. — View Citation

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance in exercise evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak)	The performance will be evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak), determinated by the cardiopulmonary exercise testing.	Three years	No
Primary	Performance in exercise evaluated by measurement the work load (W)	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.	Three years	No
Secondary	Cardiovascular responses to inspiratory muscle training	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.	Three years	No
Secondary	Respiratory responses to inspiratory muscle training	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.	Three years	No
Secondary	Metabolic responses to inspiratory muscle training	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.	Three years	No
Secondary	Autonomic responses to inspiratory muscle training	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.	Three years	No
Secondary	Metaboreflex activation to inspiratory muscle training	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.	Three years	No