HealthyPhase 2IMTNCT02984189
Effect of Inspiratory Muscle Training on Recreational Cyclists
A Phase 2 study testing Inspiratory muscle training in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)].
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Sao Carlos
São Carlos, São Paulo, 676, 13565-905
Patricia Rehder-Santos, MSc, +55 19 98118 4926, rehderpaty@hotmail.com
Aparecida M Catai, Professor, +55 16 3351 8705, rehderpaty@gmail.com
About this study
Official title: Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists: A Randomized Controlled Trial
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.
- Conditions
- Healthy
- Being tested
- Inspiratory muscle training
- Keywords
- Physical Exercise, Physical Therapy, Physical Performance, Critical Power, Respiratory Muscle
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Critical Pressure Group | Experimental | 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. Receives: Other: Inspiratory muscle training |
| 60% Maximal Inspiratory Pressure Group | Active comparator | 60% of maximal inspiratory pressure will be used for training. Receives: Other: Inspiratory muscle training |
| Sham Group | Sham comparator | 6 cmH20 will be used for training. Receives: Other: Inspiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three years
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.
Measured: Three years
Secondary outcomes (5)
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.
Measured: Three years
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.
Measured: Three years
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.
Measured: Three years
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.
Measured: Three years
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.
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aparecida Maria Catai, Universidade Federal de Sao Carlos
- Investigators
- Aparecida M Catai, PhD, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984189
- Sponsor's protocol ID
- 55990116.0.0000.5504
- Acronym
- IMT
- Status last verified
- Dec 2016
- First submitted
- 29 Nov 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12186831Garber 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.
PubMed 21694556Balady 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.
PubMed 20585013Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893HajGhanbari 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.
PubMed 22836606Hautmann 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.
PubMed 10926341Rehder-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.
PubMed 31064379
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training Using the Critical Pressure on Recreational Cyclists: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02984189
- Acronym / sponsor ID
- IMT / 55990116.0.0000.5504
- Conditions
- Healthy
- Keywords
- Physical Exercise, Physical Therapy, Physical Performance, Critical Power, Respiratory Muscle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Critical Pressure Group | Experimental | Other: Inspiratory muscle trainingInspiratory 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. |
| 60% Maximal Inspiratory Pressure Group | Active comparator | Other: Inspiratory muscle training60% of maximal inspiratory pressure will be used for training. |
| Sham Group | Sham comparator | Other: Inspiratory muscle training6 cmH20 will be used for training. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)].
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle trainingThe 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). | Other | 60% Maximal Inspiratory Pressure Group, Inspiratory Critical Pressure Group, Sham Group |
Primary outcome
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.
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.
5 secondary outcomes
Cardiovascular responses to inspiratory muscle training
Time frame: Three years
Respiratory responses to inspiratory muscle training
Time frame: Three years
Metabolic responses to inspiratory muscle training
Time frame: Three years
Autonomic responses to inspiratory muscle training
Time frame: Three years
Metaboreflex activation to inspiratory muscle training
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Background: PubMed 12186831American 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.
- Background: PubMed 21694556Garber 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.
- Background: PubMed 20585013Balady 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.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 22836606HajGhanbari 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.
- Background: PubMed 10926341Hautmann 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.
- Derived from this study: PubMed 31064379Rehder-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aparecida M Catai, PhD principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inspiratory muscle training in people with Healthy, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Rehder-Santos, Master (+55 19 98118-4926, rehderpaty@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in exercise evaluated by measurement the maximal or peak comsumption the oxygen (VO2max or peak) (time frame: Three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02984189, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.