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

NCT ID: NCT06121128

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-08-31

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)

Conditions

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Hypoxia, Altitude

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Female Control Group (FCON)

female endurance trained athletes between 18 and 44 years old

Group Type SHAM_COMPARATOR

Normal Breathing

Intervention Type PROCEDURE

No IMT performed

Female Training Group (FTRAIN)

female endurance trained athletes between 18 and 44 years old

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type 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.

Male Control Group (MCON)

male endurance trained athletes between 18 and 44 years old

Group Type SHAM_COMPARATOR

Normal Breathing

Intervention Type PROCEDURE

No IMT performed

Male Training Group (MTRAIN)

male endurance trained athletes between 18 and 44 years old

Group Type EXPERIMENTAL

Inspiratory Muscle Training (IMT)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Normal Breathing

No IMT performed

Intervention Type PROCEDURE

Other Intervention Names

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IMT

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Gregoire Millet

Prof Ordinaire

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2023-01638

Identifier Type: -

Identifier Source: org_study_id

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