Respiratory MusclesNCT07379060
Non-invasive Training of the Inspiratory Muscles in Athletic Women
A study testing Inspiratory Muscle Training 1 and Inspiratory Muscle Training 2 in people with Respiratory Muscles, run by University of Vigo at 1 site in Spain.
Trial summary
The goal of this clinical trial is to study whether there are significant differences between the control and experimental groups in terms of the improvement in lung function of the athletes who have performed Inspiratory muscle training with powerbreath. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Respiratory Muscles
- What is being tested?
- Inspiratory Muscle Training 1 and Inspiratory Muscle Training 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female athletes from the Galician Center for Sports Technification (CGTD) in the city of Pontevedra.
- Sign the informed consent document.
- Possession of the mental capacity required to participate in the study
Who cannot join
- Age below the legal healthcare age (16 years).
- Lack of skills necessary to operate the no invasive device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate a Non-invasive Training System for Inspiratory Muscles in Athletic Women
The goal of this clinical trial is to study whether there are significant differences between the control and experimental groups in terms of the improvement in lung function of the athletes who have performed Inspiratory muscle training with powerbreath. The main question it aims to answer is:
- the study that power breath is effective in providing improvements in inspiratory muscle strength, lung function, exercise capacity, quality of life, analytical parameters, dyspnea, fatigue and activities of daily living and impacting their sporting success.
Read more
Researchers will compare specific powerbreath training with nettraining period without this device.
Participants will:
- Perform regular sports training along with powerbreath training for 10 weeks
- A washout period of two months
- Perform regular sports training for 10 weeks
- Conditions
- Respiratory Muscles
- Being tested
- Inspiratory Muscle Training 1, Inspiratory Muscle Training 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training 1Device
Inspiratory Muscle Training using the no invasive device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks
Inspiratory Muscle Training 2Device
Inspiratory Muscle Training using the no invasive device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Training routine and additionally perform Inspiratory Muscle Training 1 | Experimental | The experimental 1 group will follow their regular training routine and additionally perform Inspiratory Muscle Training using the PwB Medic Plus device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks Receives: Device: Inspiratory Muscle Training 1 |
| Training routine and additionally perform Inspiratory Muscle Training 2 | Experimental | The experimental 2 group will follow their regular training routine and additionally perform Inspiratory Muscle Training using the PwB Medic Plus device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks Receives: Device: Inspiratory Muscle Training 2 |
| Normal Training routine 1 | No intervention | Normal Training routine 1 |
| Normal Training routine 2 | No intervention | Normal Training routine 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power breath. Maximum Inspiratory Pressure
This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure
Measured: From enrollment to the end of treatment at 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Sep 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory MusclesStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocío Abalo, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379060
- Sponsor's protocol ID
- CEIm 2562
- Status last verified
- Nov 2025
- First submitted
- 22 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate a Non-invasive Training System for Inspiratory Muscles in Athletic Women
- ClinicalTrials.gov ID
- NCT07379060
- Acronym / sponsor ID
- CEIm 2562
- Conditions
- Respiratory Muscles
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 30 Jan 2026 (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 goal of this clinical trial is to study whether there are significant differences between the control and experimental groups in terms of the improvement in lung function of the athletes who have performed Inspiratory muscle training with powerbreath. The main question it aims to answer is:
- the study that power breath is effective in providing improvements in inspiratory muscle strength, lung function, exercise capacity, quality of life, analytical parameters, dyspnea, fatigue and activities of daily living and impacting their sporting success.
Researchers will compare specific powerbreath training with nettraining period without this device.
Participants will:
- Perform regular sports training along with powerbreath training for 10 weeks
- A washout period of two months
- Perform regular sports training for 10 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training routine and additionally perform Inspiratory Muscle Training 1 | Experimental | Device: Inspiratory Muscle Training 1The experimental 1 group will follow their regular training routine and additionally perform Inspiratory Muscle Training using the PwB Medic Plus device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks |
| Training routine and additionally perform Inspiratory Muscle Training 2 | Experimental | Device: Inspiratory Muscle Training 2The experimental 2 group will follow their regular training routine and additionally perform Inspiratory Muscle Training using the PwB Medic Plus device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks |
| Normal Training routine 1 | No intervention | –Normal Training routine 1 |
| Normal Training routine 2 | No intervention | –Normal Training routine 2 |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female athletes from the Galician Center for Sports Technification (CGTD) in the city of Pontevedra.
- Sign the informed consent document.
- Possession of the mental capacity required to participate in the study
Key exclusion criteria (2 listed)
- Age below the legal healthcare age (16 years).
- Lack of skills necessary to operate the no invasive device
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 1Inspiratory Muscle Training using the no invasive device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks | Device | Training routine and additionally perform Inspiratory Muscle Training 1 |
| Inspiratory Muscle Training 2Inspiratory Muscle Training using the no invasive device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks | Device | Training routine and additionally perform Inspiratory Muscle Training 2 |
Primary outcome
Power breath. Maximum Inspiratory Pressure
Time frame: From enrollment to the end of treatment at 10 weeks
This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training 1 and Inspiratory Muscle Training 2 in people with Respiratory Muscles, run by University of Vigo at 1 site in Spain.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
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?
Power breath. Maximum Inspiratory Pressure (time frame: From enrollment to the end of treatment at 10 weeks). 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 3 Feb 2026.