Hypoxia, AltitudeRespiPerfNCT06121128
The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study
A study testing Inspiratory Muscle Training (IMT) and Normal Breathing in people with Hypoxia, Altitude, run by University of Lausanne.
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). Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxia, Altitude
- What is being tested?
- Inspiratory Muscle Training (IMT) and Normal Breathing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion: endurance trained athletes between 18 and 44 years old
Who cannot join
- 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)
About this study
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)
Read the 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)
- Conditions
- Hypoxia, Altitude
- Being tested
- Inspiratory Muscle Training (IMT), Normal Breathing
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT)Procedure or surgery
Also called 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 BreathingProcedure or surgery
No IMT performed
| Study group | Role | What they receive |
|---|---|---|
| Female Control Group (FCON) | Sham comparator | female endurance trained athletes between 18 and 44 years old Receives: Procedure: Normal Breathing |
| Female Training Group (FTRAIN) | Experimental | female endurance trained athletes between 18 and 44 years old Receives: Procedure: Inspiratory Muscle Training (IMT) |
| Male Control Group (MCON) | Sham comparator | male endurance trained athletes between 18 and 44 years old Receives: Procedure: Normal Breathing |
| Male Training Group (MTRAIN) | Experimental | male endurance trained athletes between 18 and 44 years old Receives: Procedure: Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One week prior and in the week immediately following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxia, AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregoire Millet, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121128
- Sponsor's protocol ID
- 2023-01638
- Other IDs
- 2023
- Acronym
- RespiPerf
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study
- ClinicalTrials.gov ID
- NCT06121128
- Acronym / sponsor ID
- RespiPerf / 2023-01638
- Conditions
- Hypoxia, Altitude
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Female Control Group (FCON) | Sham comparator | Procedure: Normal Breathingfemale endurance trained athletes between 18 and 44 years old |
| Female Training Group (FTRAIN) | Experimental | Procedure: Inspiratory Muscle Training (IMT)female endurance trained athletes between 18 and 44 years old |
| Male Control Group (MCON) | Sham comparator | Procedure: Normal Breathingmale endurance trained athletes between 18 and 44 years old |
| Male Training Group (MTRAIN) | Experimental | Procedure: Inspiratory Muscle Training (IMT)male endurance trained athletes between 18 and 44 years old |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion: endurance trained athletes between 18 and 44 years old
Key exclusion criteria (6 listed)
- cardiovascular, metabolic and respiratory diseases, smoking history, prescription medication (Two medication families are known to interfere with FC:
- Calcium channel blockers
- Beta-blockers
- Inhaled beta-agonists
- Inhaled glucocorticoids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle Training (IMT)Also: IMTThe 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. | Procedure or surgery | Female Training Group (FTRAIN), Male Training Group (MTRAIN) |
| Normal BreathingNo IMT performed | Procedure or surgery | Female Control Group (FCON), Male Control Group (MCON) |
Primary outcome
sex-differences
Time frame: One week prior and in the week immediately following the intervention
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.
Effect in hypoxia
Time frame: One week prior and in the week immediately following the intervention
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) and Normal Breathing in people with Hypoxia, Altitude, run by University of Lausanne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sex-differences (time frame: One week prior and in the week immediately following the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.