Healthy VolunteersNCT07143721
Comparison of the Effect of Different Inspiratory Loads on Diaphragmatic Function in Healthy Individuals
An observational study of Healthy Volunteers, run by University of Vigo at 1 site in Spain.
Trial summary
This pilot study aims to evaluate how the diaphragm responds to different inspiratory muscle training loads using ultrasound in healthy individuals. The observational, cross-sectional research seeks to determine whether ultrasound measurements of diaphragm movement and thickness can more effectively guide load… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2025to 1 Nov 2025
- Phase
- Observational
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers aged 18-35 years, without any history of respiratory or musculoskeletal diseases, and without conditions that could affect diaphragmatic function assessment.
Who may be able to join
- Healthy adults aged 18 to 35 years
- No history of neuromuscular, cardiovascular, respiratory, or musculoskeletal diseases that could limit participation
- Not currently on medication affecting muscle function
- Willing to provide informed consent
Who cannot join
- Pregnant women
- Recent thoracic or abdominal trauma (within the last 3 months)
- Respiratory symptoms in the last two weeks
- Conditions preventing performing forced inspiratory maneuvers
- Recent respiratory muscle training (within the last 6 months)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Fisioterapia-Universidade de Vigo
Pontevedra, España, 36005
About this study
This pilot study aims to evaluate how the diaphragm responds to different inspiratory muscle training loads using ultrasound in healthy individuals. The observational, cross-sectional research seeks to determine whether ultrasound measurements of diaphragm movement and thickness can more effectively guide load prescription, thereby optimizing the benefits of inspiratory training. Twenty healthy participants, of both sexes, aged 18 to 35 years, will be recruited through outreach at the Faculty of Physiotherapy at the University of Vigo. The assessment will include spirometry, maximum inspiratory pressure (MIP) measurement, and ultrasound evaluations of the diaphragm at various loads (10%, 30%, 50%, and 70% of the MIP). Data will be analyzed to understand how diaphragm mobility, thickness, and contraction velocity vary according to load, with the goal of improving training prescription and adjustment. The study adheres to the ethical principles of the Declaration of Helsinki and ensures strict confidentiality and participant anonymity. The results will contribute to the understanding of non-invasive diaphragm assessment and its role in enhancing respiratory and physical performance.
- Conditions
- Healthy Volunteers
- Keywords
- Diaphragm ultrasound, inspiratory muscle training, respiratory biomechanics, muscle mobility, lung function, breathing exercise, respiratory evaluation, muscle thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults undergoing inspiratory muscle training at varying intensities | Ultrasound assessment of diaphragm movement and thickness, spirometry, maximum inspiratory pressure measurement, breathing exercises at different load intensities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diaphragmatic excursion during inspiratory muscle training at varying loads
Assessment of diaphragmatic excursion using ultrasound at 10%, 30%, 50%, and 70% of maximum inspiratory pressure (MIP). Evaluates the diaphragm's mobility as a primary measure of functional response to different inspiratory loads in healthy individuals.
Measured: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP
Secondary outcomes (2)
Diaphragmatic thickness at different inspiratory loads
Measurement of diaphragmatic thickness using ultrasound at 10%, 30%, 50%, and 70% of maximum inspiratory pressure (MIP). This evaluates muscular response and mobility related to varying inspiratory efforts in healthy subjects.
Measured: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP
Diaphragmatic contraction velocity at different inspiratory loads
Assessment of diaphragmatic contraction velocity using ultrasound at 10%, 30%, 50%, and 70% of MIP. Evaluates muscular response and mobility during inspiratory efforts.
Measured: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start30 Jun 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva María Lantarón Caeiro, University of Vigo
- Investigators
- Eva María Lantarón Caeiro L Dra Eva María Lantarón Caeiro, Dra, Principal investigator, Universidad de Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143721
- Sponsor's protocol ID
- Muscle training
- Status last verified
- Aug 2025
- First submitted
- 24 Jun 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share IPD has not yet been made. The data will be stored securely and may be considered for sharing in the future, depending on institutional policies, participant consent, and study outcomes.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Different Inspiratory Loads on Diaphragmatic Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07143721
- Acronym / sponsor ID
- Muscle training
- Conditions
- Healthy Volunteers
- Keywords
- Diaphragm ultrasound, inspiratory muscle training, respiratory biomechanics, muscle mobility, lung function, breathing exercise, respiratory evaluation, muscle thickness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 27 Aug 2025 (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.
This pilot study aims to evaluate how the diaphragm responds to different inspiratory muscle training loads using ultrasound in healthy individuals. The observational, cross-sectional research seeks to determine whether ultrasound measurements of diaphragm movement and thickness can more effectively guide load prescription, thereby optimizing the benefits of inspiratory training. Twenty healthy participants, of both sexes, aged 18 to 35 years, will be recruited through outreach at the Faculty of Physiotherapy at the University of Vigo. The assessment will include spirometry, maximum inspiratory pressure (MIP) measurement, and ultrasound evaluations of the diaphragm at various loads (10%, 30%, 50%, and 70% of the MIP). Data will be analyzed to understand how diaphragm mobility, thickness, and contraction velocity vary according to load, with the goal of improving training prescription and adjustment. The study adheres to the ethical principles of the Declaration of Helsinki and ensures strict confidentiality and participant anonymity. The results will contribute to the understanding of non-invasive diaphragm assessment and its role in enhancing respiratory and physical performance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults undergoing inspiratory muscle training at varying intensities | – | –Ultrasound assessment of diaphragm movement and thickness, spirometry, maximum inspiratory pressure measurement, breathing exercises at different load intensities. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers aged 18-35 years, without any history of respiratory or musculoskeletal diseases, and without conditions that could affect diaphragmatic function assessment.
Key inclusion criteria (4 listed)
- Healthy adults aged 18 to 35 years
- No history of neuromuscular, cardiovascular, respiratory, or musculoskeletal diseases that could limit participation
- Not currently on medication affecting muscle function
- Willing to provide informed consent
Key exclusion criteria (5 listed)
- Pregnant women
- Recent thoracic or abdominal trauma (within the last 3 months)
- Respiratory symptoms in the last two weeks
- Conditions preventing performing forced inspiratory maneuvers
- Recent respiratory muscle training (within the last 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in diaphragmatic excursion during inspiratory muscle training at varying loads
Time frame: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP
Assessment of diaphragmatic excursion using ultrasound at 10%, 30%, 50%, and 70% of maximum inspiratory pressure (MIP). Evaluates the diaphragm's mobility as a primary measure of functional response to different inspiratory loads in healthy individuals.
2 secondary outcomes
Diaphragmatic thickness at different inspiratory loads
Time frame: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP
Diaphragmatic contraction velocity at different inspiratory loads
Time frame: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP
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 27 Aug 2025.
- Individual participant dataSharing planned: Undecided. The decision to share IPD has not yet been made. The data will be stored securely and may be considered for sharing in the future, depending on institutional policies, participant consent, and study outcomes.
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Screening Protocol
Pain
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.
Eva María Lantarón Caeiro L Dra Eva María Lantarón Caeiro, Dra principal investigator
Universidad de Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, 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 4 inclusion and 5 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 27 Aug 2025. 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?
Change in diaphragmatic excursion during inspiratory muscle training at varying loads (time frame: Day 2: Baseline; Immediately after 10% MIP; Immediately after 30% MIP; Immediately after 50% MIP; Immediately after 70% MIP). 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 27 Aug 2025.