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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Hypoxia, Altitude
• Intervention / Treatment: Procedure: Normal Breathing; Procedure: Inspiratory Muscle Training (IMT)

Detailed Description

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)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Female Control Group (FCON); female endurance trained athletes between 18 and 44 years old	Procedure: Normal Breathing; No IMT performed
Experimental: Female Training Group (FTRAIN); female endurance trained athletes between 18 and 44 years old	Procedure: Inspiratory Muscle Training (IMT); 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.; Other Names: IMT
Sham Comparator: Male Control Group (MCON); male endurance trained athletes between 18 and 44 years old	Procedure: Normal Breathing; No IMT performed
Experimental: Male Training Group (MTRAIN); male endurance trained athletes between 18 and 44 years old	Procedure: Inspiratory Muscle Training (IMT); 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.; Other Names: IMT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Lausanne

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Altitude Sickness; Hypoxia
• Other Study ID Numbers: 2023-01638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No