The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study

Study Overview
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Brief Summary
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The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance. Intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening. Resistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week. Four laboratory visits: 2 pre-tests and 2 post-tests. Each pre- / post- test will go under normoxic and hypoxic conditions. Measurements include Pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. VO2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)

Detailed Description
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The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance. Intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening. Resistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week. Four laboratory visits: 2 pre-tests and 2 post-tests. Each pre- / post- test will go under normoxic and hypoxic conditions. Measurements include Pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. VO2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)

Official Title
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The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study

Conditions
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Hypoxia, Altitude

Intervention / Treatment
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* Procedure: Inspiratory Muscle Training (IMT)
* Procedure: Normal Breathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion: endurance trained athletes between 18 and 44 years old Exclusion Criteria: cardiovascular, metabolic and respiratory diseases, smoking history, prescription medication (Two medication families are known to interfere with FC: Calcium channel blockers Beta-blockers Two families are known to interfere during spirometry measurements: Inhaled beta-agonists Inhaled glucocorticoids)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial (RCT): with a Female Control Group (FCON), a Male Control Group (MCON), a Female Training Group (FTRAIN), a Male Training Group (MTRAIN)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Female Control Group (FCON)<br>female endurance trained athletes between 18 and 44 years old | Procedure: Normal Breathing<br>* No IMT performed<br>|
| Experimental: Female Training Group (FTRAIN)<br>female endurance trained athletes between 18 and 44 years old | Procedure: Inspiratory Muscle Training (IMT)<br>* The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance. Intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening. Resistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.<br>* Other names: IMT;|
| Sham Comparator: Male Control Group (MCON)<br>male endurance trained athletes between 18 and 44 years old | Procedure: Normal Breathing<br>* No IMT performed<br>|
| Experimental: Male Training Group (MTRAIN)<br>male endurance trained athletes between 18 and 44 years old | Procedure: Inspiratory Muscle Training (IMT)<br>* The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance. Intervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening. Resistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.<br>* Other names: IMT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sex-differences | Primary objective: To assess the change of a time limit duration in ergocycle after 4 weeks of inspiratory muscle training (IMT) between males and females. | One week prior and in the week immediately following the intervention | 
| Effect in hypoxia | Secondary objective: To assess the change of a time limit duration in ergocycle after 4 weeks of inspiratory muscle training (IMT) between hypoxia and normoxia. | One week prior and in the week immediately following the intervention |