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Active, Not Recruiting

NCT Number: NCT07143721

Comparison of the Effect of Different Inspiratory Loads on Diaphragmatic Function in Healthy Individuals

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Facultad de Fisioterapia-Universidade de Vigo

Pontevedra, España, 36005, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. 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

    Assessment of diaphragmatic contraction velocity using ultrasound at 10%, 30%, 50%, and 70% of MIP. Evaluates muscular response and mobility during inspiratory efforts.

Other outcomes

  1. Correlation between ultrasound measurements of diaphragmatic function and spirometry parameters

    Time frame: Day 1: Spirometry session, prior to ultrasound evaluations. Day 2: Ultrasound evaluations: Baseline (reposo, pre-load); Immediately after 10% PIM; Immediately after 30% PIM; Immediately after 50% PIM; Immediately after 70% PIM.

    Analysis of the relationship between ultrasound measurements of diaphragmatic function (excursion, thickness, and contraction velocity) and spirometry parameters (such as FEV1, FVC, PEF) obtained in a separate session, to evaluate how ultrasound indicators reflect overall respiratory capacity in healthy individuals.

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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