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SwimmingNCT07595341

Effects of Inspiratory Training on Respiratory Function in Swimming

A study testing Inspiratory training in people with Swimming and Inspiratory Muscle Strength, run by Universidad Rey Juan Carlos at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Introduction: The diaphragm is the primary inspiratory muscle and plays a key role in ventilation, trunk stability, and exercise efficiency. Its dysfunction is associated with early fatigue, increased respiratory work, and reduced performance. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Inspiratory training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteSpain
Study dates
Sep 2026to Jan 2027
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants of both sexes, aged over 18 years.
  • Minimum swimming training frequency of at least two sessions per week, with a minimum duration of 30 minutes per session, consistently maintained over the last three months.

Who cannot join

  • Current or previous diagnosis of respiratory diseases.
  • Musculoskeletal injuries limiting the ability to perform a 100-meter swimming test.
  • Participation in inspiratory muscle training programs within the last six months.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site
  • Club de natación Moscardó

    Madrid

Other trials in Spain

About this study

Official title: Effects of Inspiratory Training on Respiratory Function, Diaphragmatic Structure, and Cardiac Response in Healthy Adults During Aquatic Exercise.

Introduction:

The diaphragm is the primary inspiratory muscle and plays a key role in ventilation, trunk stability, and exercise efficiency. Its dysfunction is associated with early fatigue, increased respiratory work, and reduced performance. Inspiratory muscle training (IMT) has been shown to improve respiratory function and exercise tolerance. Swimming, due to its specific characteristics, imposes an additional demand on the respiratory muscles.

Read more

Objective:

To evaluate the effects of an IMT program on diaphragmatic function, respiratory variables, cardiorespiratory response, and performance in swimmers.

Methods:

A randomized, parallel, double-blind clinical trial with 34 swimmers. The experimental group will perform an 8-week IMT program with progressive loads, while the control group will use a sham device without resistance. Diaphragmatic function will be assessed using ultrasound (thickness and excursion), along with respiratory variables (MIP, FEV₁, MEP, FVC), cardiovascular variables (heart rate, HRV), metabolic variables (lactate), and performance (100 m test).

Expected results:

IMT is expected to improve diaphragmatic function, increase inspiratory muscle strength, enhance ventilatory efficiency, and reduce respiratory fatigue, leading to improvements in performance and physiological responses to exercise.

Conclusion:

IMT could be an effective strategy to enhance respiratory function and swimming performance. This study provides a novel approach by incorporating ultrasound assessment of the diaphragm in an aquatic exercise context.

Read the detailed description

Diaphragm

The diaphragm is the primary muscle of inspiration. It is a dome-shaped skeletal muscle located between the thoracic and abdominal cavities. Its contraction increases thoracic volume, allowing air to enter the lungs. Beyond respiration, it contributes to core stability and postural control during movement and exercise.

Inspiratory Muscle Training (IMT)

IMT is a training method that involves breathing against a resistive load to strengthen the inspiratory muscles, mainly the diaphragm and accessory muscles. It is used to improve respiratory strength, endurance, and ventilatory efficiency, especially in athletes and clinical populations.

Respiratory function

Respiratory function refers to the ability of the respiratory system to ventilate, exchange gases, and maintain adequate oxygen and carbon dioxide levels. It is commonly assessed using spirometric and pressure-based measures.

Diaphragmatic dysfunction

This refers to a reduced ability of the diaphragm to generate force or excursion, leading to impaired ventilation. It may result in increased breathing effort, reduced exercise tolerance, and earlier onset of respiratory fatigue.

Maximal Inspiratory Pressure (MIP)

MIP is the maximum negative pressure generated during a forceful inspiration against an occluded airway. It is a key indicator of inspiratory muscle strength, especially diaphragmatic function.

Forced Expiratory Volume in 1 second (FEV₁)

FEV₁ is the volume of air that can be forcefully exhaled in the first second of a forced expiration. It is a standard measure of airway function and pulmonary performance.

Maximal Expiratory Pressure (MEP)

MEP represents the maximum pressure generated during a forceful expiration. It reflects the strength of expiratory muscles such as abdominal and intercostal muscles.

Forced Vital Capacity (FVC)

FVC is the total volume of air exhaled forcefully after a maximal inspiration. It reflects lung capacity and ventilatory function.

Heart rate

Heart rate is the number of heartbeats per minute. It reflects cardiovascular response to exercise intensity and autonomic nervous system activity.

Heart Rate Variability (HRV)

HRV is the variation in time intervals between consecutive heartbeats. It is a marker of autonomic nervous system balance, particularly sympathetic and parasympathetic activity.

Blood lactate

Blood lactate is a metabolic byproduct of anaerobic glycolysis. Elevated levels indicate increased reliance on anaerobic energy systems and higher metabolic stress during intense exercise.

100-meter swimming test

A standardized performance test measuring the time required to complete 100 meters freestyle swimming at maximal effort. It is used to assess anaerobic and aerobic performance capacity in swimmers.

Randomized controlled trial (RCT)

An experimental study design in which participants are randomly assigned to different intervention groups to reduce bias and ensure comparability.

Parallel design

A study design where two or more groups are followed simultaneously, each receiving a different intervention throughout the study period.

Double-blind design

A methodological approach in which neither participants nor researchers know group allocation, minimizing expectation and measurement bias.

Sham device (placebo IMT)

A device designed to mimic IMT without providing meaningful resistance, used to control for placebo effects in training studies.

Ultrasound assessment

A non-invasive imaging technique used to evaluate diaphragm structure and function in real time, including thickness and movement during breathing.

Diaphragmatic thickness

The measurement of the muscle layer of the diaphragm, often assessed at rest and during contraction to evaluate contractile capacity.

Diaphragmatic excursion

The movement amplitude of the diaphragm during breathing, reflecting its functional mobility and efficiency.

Being tested
Placebo, Inspiratory training
Keywords
sport performance, IMT, RPE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDevice

    The control group will use the same device without resistance, maintaining the same breathing frequency and volume to control for the placebo effect.

  • Inspiratory trainingDevice

    The experimental group will perform an eight-week home-based training program using the POWERbreathe EX1-MR device, individually calibrated according to MIP. Participants will complete 30 deep inspirations per session, twice daily, seven days a week, with progressive intensities: 30% of initial MIP during weeks 1-2, 50% of the new MIP during weeks 3-4, 60% during weeks 5-6, and 70% of MIP during weeks 7-8, with the aim of familiarizing participants with the device and progressively adapting the diaphragm to increasing loads.

Study groups in NCT07595341
Study groupRoleWhat they receive
Inspiratory trainingActive comparatorThe experimental group will perform an eight-week home-based training program using the POWERbreathe EX1-MR device, individually calibrated according to MIP. Participants will complete 30 deep inspirations per session, twice daily, seven days per week, with progressive intensities: 30% of initial MIP during weeks 1-2, 50% of the new MIP during weeks 3-4, 60% during weeks 5-6, and 70% of MIP during weeks 7-8, with the aim of familiarizing participants with the device and progressively adapting the diaphragm to increasing loads.
Receives: Device: Inspiratory training
PlaceboPlacebo comparatorThe control group will use the same device without resistance, maintaining the same breathing frequency and volume in order to control for the placebo effect.
Receives: Device: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sport performance

    Total time and split times for completing 100 m freestyle.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  2. Maximal inspiratory pressure.

    Inspiratory variables: Inspiratory muscle strength was assessed by measuring MIP using the POWERbreathe Smart Adaptor device. The participant was seated and used a mouthpiece with a leak hole to minimize activation of the orofacial musculature. The procedure consisted of a maximal expiration to residual volume, followed by a maximal inspiration sustained against the device for at least 2 seconds. Three attempts were performed with rest periods of at least 1 minute, and the highest value was selected.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  3. Maximal espiratory pressure.

    Expiratory variables: Pulmonary function was assessed using forced spirometry, recording FEV₁, MEP, and FVC with the MIR Spirobank Oxi Portable Spirometer device. For a manoeuvre to be acceptable, the subject had to perform a maximal inspiration followed by a rapid and continuous forced expiration, without coughing during the first second and with a smooth flow-volume curve, without leaks. The expiration had to last at least 6 seconds or until a volume plateau was reached. Manoeuvres with interruptions, false efforts, or closed glottis were discarded. Three acceptable manoeuvres were performed, and results were considered valid when the two best FEV₁ and FVC values differed by less than 150 mL. If this variability criterion was not met, additional attempts were performed until reproducible results were obtained.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

Secondary outcomes (6)
  1. lactate

    It will be taken from the fingertip immediately after completing the test, following the extraction protocol to ensure measurement validity. The device will be calibrated before each testing session according to the manufacturer's recommendations.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  2. Perceived exertion.

    The Borg scale (6-20) will be previously explained to the participant using standardized instructions to ensure full understanding. Perceived intensity will be recorded immediately after the test through a direct interview with the evaluator.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  3. Dysnea

    It will be administered verbally and individually by the evaluator immediately after physical exertion, ensuring that the participant understands each item. The test consists of 12 questions rated on a 0-3 Likert scale for each item.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  4. Heart rate.

    It will be placed on the anterior thoracic region, just below the xiphoid process. The device will be calibrated and checked according to the manufacturer's instructions before each test. Heart rate will be recorded in real time from the start until five minutes after the test. Data will be analyzed using Polar Flow software, including mean heart rate (HRmean), maximum heart rate (HRmax), recovery time (RT), and heart rate variability (HRV). The data will then be further analyzed in Polar Flow.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  5. Diaphragmatic excursion

    It was assessed on the right hemidiaphragm to ensure an adequate acoustic window. The transducer was placed in the anterior subcostal region at the midclavicular line, with a craniocaudal orientation and slight medial angulation. First, B-mode ultrasound was used to identify the diaphragmatic dome as a hyperechoic, mobile line. Subsequently, M-mode was activated, aligning the cursor perpendicular to the diaphragmatic movement, and vertical displacement was recorded from the end of quiet expiration to maximal voluntary inspiration. Three valid manoeuvres were performed, and the highest value was selected for analysis, expressed in centimeters.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

  6. Diaphragmatic thickening

    It was assessed by placing the transducer in the diaphragm's zone of apposition, located between the 8th and 10th intercostal spaces along the midaxillary line. In B-mode, the diaphragm was identified as a hypoechoic structure bounded by two hyperechoic lines corresponding to the pleura and peritoneum. Diaphragmatic thickness was measured at the end of quiet expiration and during maximal voluntary inspiration. Three consecutive respiratory cycles were recorded, and the mean value was used for final analysis.

    Measured: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Investigator
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595341
Sponsor's protocol ID
150120261552026
Other IDs
Sponsor-Investigator
Status last verified
Apr 2026
First submitted
18 Apr 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan description: At present, no definitive decision has been made regarding the sharing of individual participant data. The possibility of sharing anonymized data with other researchers is being considered in order to promote scientific transparency, reproducibility of results, and the development of future research. However, this decision will be subject to strict compliance with applicable data protection regulations (GDPR), the safeguarding of participant confidentiality, and the evaluation of the sample size and the specific context of the study. If data are shared, they will be provided exclusively in anonymized format, upon justified request and under formal data use agreements.

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory training in people with Swimming and Inspiratory Muscle Strength, run by Universidad Rey Juan Carlos 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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 19 May 2026. 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. Some participants in this study may receive a placebo. 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?

Sport performance (time frame: This measurement will be carried out from the randomization process until 8 weeks after the start of the inspiratory training program.). The study lists 3 primary outcomes in all. 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 19 May 2026.

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