NCT07046637

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

26 days

First QC Date

June 29, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

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.

    Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention

Secondary Outcomes (1)

  • Diaphragmatic thickness and thickening fraction

    Immediately before intervention, immediately after intervention, 15 minutes post intervention and 30 minutes post intervention

Study Arms (2)

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.

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.

Device: Inspiratory muscle warm-up group

Interventions

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

Also known as: Inspiratory muscle fatigue
Inspiratory muscle fatigue group

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

Also known as: Inspiratory muscle warm-up
Inspiratory muscle warm-up group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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 Jan 6. doi: 10.1007/s00421-025-06116-2. Online ahead of print.

MeSH Terms

Conditions

Athletic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Arturo Ladriñan, PhD

CONTACT

eva V sanz

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2025

First Posted

July 1, 2025

Study Start

July 10, 2025

Primary Completion

August 5, 2025

Study Completion

August 12, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

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.