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NCT06121128 Clinical Trial

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

Hypoxia, Altitude Clinical Trial

— RespiPerf  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06121128
Other study ID # 2023-01638
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2023
Est. completion date August 31, 2024

Study information
Verified date November 2023
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)

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)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 48
Est. completion date August 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 44 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• Normal Breathing
No IMT performed

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Lausanne

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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