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Not yet recruitingNCT07046637Updated Jul 3, 2025

Acute Effects of Inspiratory Muscle Load on Diaphragmatic Recovery in Athletes

An interventional study of Inspiratory muscle fatigue group and Inspiratory muscle warm-up group in Sports Physical Therapy, Athletic Injuries and Healthy, sponsored by Sierra Varona SL. Not yet recruiting. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.

Sponsored by Sierra Varona SL · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Sports Physical Therapy
  • Athletic Injuries
  • Healthy

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03

In context

Athletic Injuries

258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.

This study's planned enrollment of 38 is below the median of 44 across 164 interventional studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

Sierra Varona SL is the lead sponsor of 16 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Inability to understand or follow study instructions.
  • Tympanic membrane perforation or middle/inner ear pathology.
  • Pregnancy or postpartum period within the last 6 months.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Inspiratory muscle fatigue group

    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.

    Device: Inspiratory muscle fatigue group

  • Active comparator
    Inspiratory muscle warm-up group

    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.

    Device: Inspiratory muscle warm-up group

Interventions

  • DeviceInspiratory muscle fatigue group

    The subjects will perform deep inspirations against a threshold device with varying resistances

    Also known as: Inspiratory muscle fatigue

  • DeviceInspiratory muscle warm-up group

    The subjects will perform deep inspirations against a threshold device with varying resistances

    Also known as: Inspiratory muscle warm-up

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07046637
Lead sponsor
Sierra Varona SL
Collaborators
Universidad Francisco de Vitoria
Responsible party
Sponsor
First posted
Jul 1, 2025
Start date
Jul 10, 2025 (estimated)
Primary completion
Aug 5, 2025 (estimated)
Completion
Aug 12, 2025 (estimated)
Last update
Jul 3, 2025

Study contacts

Arturo Ladriñan, PhD
Contact
arturo.ladrinan@uclm.es
925 26 88 00
eva V sanz
Contact
925 23 10 52

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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