- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984189
Effect of Inspiratory Muscle Training on Recreational Cyclists (IMT)
Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists: A Randomized Controlled Trial
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Patricia Rehder-Santos, Master
- Phone Number: +55 19 98118-4926
- Email: rehderpaty@hotmail.com
Study Locations
-
-
Sao Paulo
-
Sao Carlos, Sao Paulo, Brazil, 676, 13565-905
- Recruiting
- Federal University of São Carlos
-
Contact:
- Patricia Rehder-Santos, MSc
- Phone Number: +55 19 98118 4926
- Email: rehderpaty@hotmail.com
-
Contact:
- Aparecida M Catai, Professor
- Phone Number: +55 16 3351 8705
- Email: rehderpaty@gmail.com
-
Sub-Investigator:
- Raphael M Abreu
-
Sub-Investigator:
- Étore F Signini
-
Sub-Investigator:
- Camila A Sagaguchi, MSc
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Principal Investigator:
- Aparecida M Catai, Professor
-
Sub-Investigator:
- Patricia Rehder-Santos, MSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Three years
|
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. |
Three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Three years
|
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. |
Three years
|
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. |
Three years
|
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. |
Three years
|
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. |
Three years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Aparecida M Catai, pHD, Universidade Federal de Sao Carlos
Publications and helpful links
General Publications
- Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rehder-Santos P, Minatel V, Milan-Mattos JC, Signini EF, de Abreu RM, Dato CC, Catai AM. Critical inspiratory pressure - a new methodology for evaluating and training the inspiratory musculature for recreational cyclists: study protocol for a randomized controlled trial. Trials. 2019 May 7;20(1):258. doi: 10.1186/s13063-019-3353-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 55990116.0.0000.5504
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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