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

NCT06121128 | Unknown DMC

• 1 other identifier: 2023-01638
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Hypoxia, Altitude

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Female Control Group (FCON)

SHAM COMPARATOR

female endurance trained athletes between 18 and 44 years old

Procedure: Normal Breathing

Female Training Group (FTRAIN)

EXPERIMENTAL

female endurance trained athletes between 18 and 44 years old

Procedure: Inspiratory Muscle Training (IMT)

Male Control Group (MCON)

SHAM COMPARATOR

male endurance trained athletes between 18 and 44 years old

Procedure: Normal Breathing

Male Training Group (MTRAIN)

EXPERIMENTAL

male endurance trained athletes between 18 and 44 years old

Procedure: Inspiratory Muscle Training (IMT)

Interventions

Inspiratory Muscle Training (IMT) PROCEDURE

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.

Also known as: IMT

Female Training Group (FTRAIN); Male Training Group (MTRAIN)

Normal Breathing PROCEDURE

No IMT performed

Female Control Group (FCON); Male Control Group (MCON)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Lausanne: lead

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Ordinaire

Model Details: 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)

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 7, 2023
• Study Start: December 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: August 31, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share