Sports Physical TherapyNCT07046637
Acute Effects of Inspiratory Muscle Load on Diaphragmatic Recovery in Athletes
A study testing Inspiratory muscle fatigue group and Inspiratory muscle warm-up group in people with Sports Physical Therapy and Athletic Injuries, run by Sierra Varona SL.
Trial summary
This randomized controlled trial investigates the acute effects of inspiratory muscle warm-up and fatigue on diaphragmatic function in professional basketball players. Using ultrasound imaging and maximal inspiratory pressure (PIM) assessment, the study evaluates changes in diaphragmatic thickness and respiratory… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy, Athletic Injuries, Healthy
- What is being tested?
- Inspiratory muscle fatigue group and Inspiratory muscle warm-up group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2025to 12 Aug 2025
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female professional basketball players aged between 18 and 35 years.
- Holding a valid federation license at the autonomous or higher competitive level.
- A minimum of 3 consecutive seasons of competition in official FEB, FIBA, or equivalent regional leagues.
- Regular training frequency of ≥4 sessions per week over the past 6 months.
- No previous experience with inspiratory muscle training.
- Ability to understand study procedures and provide written informed consent.
Who cannot join
- History of chronic respiratory, neuromuscular, or cardiovascular disease.
- Musculoskeletal injury limiting inspiratory effort or physical participation (current or within the past three months).
- Previous thoracic or abdominal surgery.
- Current smokers.
- Use of pharmacological treatments that could affect respiratory or muscular function.
- Participation in another interventional study within the past 4 weeks.
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- Inability to understand or follow study instructions.
- Tympanic membrane perforation or middle/inner ear pathology.
- Pregnancy or postpartum period within the last 6 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
eva V sanz contact
About this study
Official title: Short-Term Effects of Inspiratory Muscle Warm-Up and Fatigue on Diaphragmatic Function in Professional Basketball Players: A Randomized Controlled Trial
This randomized controlled trial investigates the acute effects of inspiratory muscle warm-up and fatigue on diaphragmatic function in professional basketball players. Using ultrasound imaging and maximal inspiratory pressure (PIM) assessment, the study evaluates changes in diaphragmatic thickness and respiratory strength before and after specific inspiratory muscle loading protocols. Findings aim to clarify the short-term impact of these interventions on diaphragmatic recovery capacity, with potential implications for respiratory training, performance enhancement, and injury prevention strategies in elite athletic populations.
- Conditions
- Sports Physical Therapy, Athletic Injuries, Healthy
- Being tested
- Inspiratory muscle fatigue group, Inspiratory muscle warm-up group
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle fatigue groupDevice
Also called Inspiratory muscle fatigue
The subjects will perform deep inspirations against a threshold device with varying resistances
Inspiratory muscle warm-up groupDevice
Also called Inspiratory muscle warm-up
The subjects will perform deep inspirations against a threshold device with varying resistances
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle fatigue group | Experimental | The EG (experimental group) will perform the diaphragmatic fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their MIP (Maximum Inspiratory Pressure) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts. Receives: Device: Inspiratory muscle fatigue group |
| Inspiratory muscle warm-up group | Active comparator | The inspiratory muscle warm-up group will perform the protocol of 2 sets of 30 repetitions at 40% of their MIP, one-on-one, and in a single session, breathing against submaximal inspiratory loads using a threshold valve device. The participants will follow a free pattern of breathing until complete the protocol. Receives: Device: Inspiratory muscle warm-up group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
It will be assessed using a Breathare MIP/MEP® (GH Innotek Co., Ltd., Busan, Republic of Korea).The Breathare MIP/MEP® is likely a respiratory pressure meter or manometer designed for measuring respiratory muscle strength. It typically includes a mouthpiece connected to a pressure sensor, and the device measures the force or pressure generated during respiratory maneuvers.
The person will be instructed to take a maximal deep breath in, and then exhale to residual volume. After that, they will be asked to inhale forcefully against the resistance provided by the Breathare MIP/MEP®. This measures the strength of the inspiratory muscles.
The measures will be expressed in cmH2O.
Measured: Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention
Secondary outcomes (1)
Diaphragmatic thickness and thickening fraction
The linear array probe with a frequency of 3.0-10 megahertz (MHz) is placed perpendicularly to chest wall close to the mid-axillary line which is between the 8th and 10th intercostal space. The thickness of diaphragm is measured at the end of expiration and maximum inspiration for three times and the average values were recorded.
The measures will be expressed in centimeters.
Measured: Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion5 Aug 2025 (estimated)
- Study completion12 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sports Physical TherapyStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sierra Varona SL
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Francisco de Vitoria
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046637
- Sponsor's protocol ID
- 020
- Status last verified
- Jul 2025
- First submitted
- 29 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to confidentiality and privacy considerations, individual participant data (IPD) will not be publicly available. However, de-identified data can be made available upon reasonable request to the corresponding author, subject to approval and adherence to ethical guidelines. The anonymity of participants will always be strictly maintained.
Publications
Ladrinan-Maestro A, Sanchez-Infante J, Rodriguez-Sanz D, Sanchez-Sierra A. Short-term effects of inspiratory muscle warm-up and fatigue on diaphragmatic function in professional basketball players: a randomized clinical trial. Eur J Appl Physiol. 2026 May;126(5):2935-2943. doi: 10.1007/s00421-025-06116-2. Epub 2026 Jan 6.
PubMed 41493585
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of Inspiratory Muscle Warm-Up and Fatigue on Diaphragmatic Function in Professional Basketball Players: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07046637
- Acronym / sponsor ID
- 020
- Conditions
- Sports Physical Therapy, Athletic Injuries, Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Sierra Varona SLUniversity, hospital or other
- Collaborators
- Universidad Francisco de Vitoria
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 5 Aug 2025 (estimated)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 1 Jul 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 randomized controlled trial investigates the acute effects of inspiratory muscle warm-up and fatigue on diaphragmatic function in professional basketball players. Using ultrasound imaging and maximal inspiratory pressure (PIM) assessment, the study evaluates changes in diaphragmatic thickness and respiratory strength before and after specific inspiratory muscle loading protocols. Findings aim to clarify the short-term impact of these interventions on diaphragmatic recovery capacity, with potential implications for respiratory training, performance enhancement, and injury prevention strategies in elite athletic populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle fatigue group | Experimental | Device: Inspiratory muscle fatigue groupThe EG (experimental group) will perform the diaphragmatic fatigue protocol using a specific inspiratory endurance test, in which volunteers, one-on-one, and in a single session, will breathe against submaximal inspiratory loads equivalent to 60% of their MIP (Maximum Inspiratory Pressure) through a threshold valve device. The participants will follow a free pattern of breathing until they are unable to establish flow during at least 3 maximum inspiratory efforts. |
| Inspiratory muscle warm-up group | Active comparator | Device: Inspiratory muscle warm-up groupThe inspiratory muscle warm-up group will perform the protocol of 2 sets of 30 repetitions at 40% of their MIP, one-on-one, and in a single session, breathing against submaximal inspiratory loads using a threshold valve device. The participants will follow a free pattern of breathing until complete the protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female professional basketball players aged between 18 and 35 years.
- Holding a valid federation license at the autonomous or higher competitive level.
- A minimum of 3 consecutive seasons of competition in official FEB, FIBA, or equivalent regional leagues.
- Regular training frequency of ≥4 sessions per week over the past 6 months.
- No previous experience with inspiratory muscle training.
Key exclusion criteria (9 listed)
- History of chronic respiratory, neuromuscular, or cardiovascular disease.
- Musculoskeletal injury limiting inspiratory effort or physical participation (current or within the past three months).
- Previous thoracic or abdominal surgery.
- Current smokers.
- Use of pharmacological treatments that could affect respiratory or muscular function.
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 fatigue groupAlso: Inspiratory muscle fatigueThe subjects will perform deep inspirations against a threshold device with varying resistances | Device | Inspiratory muscle fatigue group |
| Inspiratory muscle warm-up groupAlso: Inspiratory muscle warm-upThe subjects will perform deep inspirations against a threshold device with varying resistances | Device | Inspiratory muscle warm-up group |
Primary outcome
Maximal inspiratory pressure
Time frame: Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention
It will be assessed using a Breathare MIP/MEP® (GH Innotek Co., Ltd., Busan, Republic of Korea).The Breathare MIP/MEP® is likely a respiratory pressure meter or manometer designed for measuring respiratory muscle strength. It typically includes a mouthpiece connected to a pressure sensor, and the device measures the force or pressure generated during respiratory maneuvers. The person will be instructed to take a maximal deep breath in, and then exhale to residual volume. After that, they will be asked to inhale forcefully against the resistance provided by the Breathare MIP/MEP®. This measures the strength of the inspiratory muscles. The measures will be expressed in cmH2O.
1 secondary outcome
Diaphragmatic thickness and thickening fraction
Time frame: Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention
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 Jul 2025.
- Derived from this study: PubMed 41493585Ladrinan-Maestro A, Sanchez-Infante J, Rodriguez-Sanz D, Sanchez-Sierra A. Short-term effects of inspiratory muscle warm-up and fatigue on diaphragmatic function in professional basketball players: a randomized clinical trial. Eur J Appl Physiol. 2026 May;126(5):2935-2943. doi: 10.1007/s00421-025-06116-2. Epub 2026 Jan 6.
- Individual participant dataSharing planned: No. Due to confidentiality and privacy considerations, individual participant data (IPD) will not be publicly available. However, de-identified data can be made available upon reasonable request to the corresponding author, subject to approval and adherence to ethical guidelines. The anonymity of participants will always be strictly maintained.
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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.
eva V sanz contact
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle fatigue group and Inspiratory muscle warm-up group in people with Sports Physical Therapy and Athletic Injuries, run by Sierra Varona SL.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 3 Jul 2025. 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. 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?
Contact Arturo Ladriñan, PhD (925 26 88 00, arturo.ladrinan@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (time frame: Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07046637, which also lists 1 linked publication.
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 Jul 2025.