NCT07595328

Brief Summary

Objective To evaluate the acute effect of four inspiratory warm-up intensities (15%, 40%, 60%, and 80% of maximal inspiratory pressure \[MIP\]) on 100 m freestyle performance, and to analyze their impact on heart rate, blood lactate concentration, perceived exertion, and dyspnea in trained swimmers. Methods A randomized, crossover, double-blind experimental study was conducted. Participants were swimmers aged ≥18 years, with no respiratory or musculoskeletal pathology. Each participant completed, in sessions separated by at least three days, an inspiratory muscle warm-up consisting of 30 breaths against resistive loads set at 15%, 40%, 60%, and 80% of their MIP, previously determined using standardized procedures. Following each intervention, participants performed a maximal 100 m freestyle test. The following variables were recorded: Swimming time Heart rate (during and post-exercise) Post-exercise capillary blood lactate concentration Rating of perceived exertion (Borg scale) Dyspnea (Dyspnea-12) Conclusions This study will help identify the optimal inspiratory warm-up intensity to enhance swimming performance.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2026

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

April 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 19, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

April 19, 2026

Last Update Submit

May 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • swimming time (100 meters)

    After the respiratory interventions, participants will perform a maximal 100-meter freestyle swimming test under supervision. The total time will be recorded using a digital stopwatch, starting with the starting signal and ending when the swimmer touches the wall upon completing the distance.

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

Secondary Outcomes (8)

  • Maximal Inspiratory Pressure and Maximal Expiratory Pressure

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

  • Lactate

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

  • Perceived exertion.

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

  • Dysnea

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

  • Heart rate.

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

  • +3 more secondary outcomes

Study Arms (4)

IMT: 15%

EXPERIMENTAL

The study will apply four respiratory warm-up intensities (15%, 40%, 60%, and 80% of maximal inspiratory pressure) to compare their acute effects on these variables. This graded loading approach will allow identification of the optimal dose capable of maximizing diaphragmatic neuromuscular activation without inducing early fatigue, leveraging the post-activation potentiation phenomenon to improve respiratory efficiency and swimming performance.

Device: POWERbreath

IMT:40%

EXPERIMENTAL

The study will apply four respiratory warm-up intensities (15%, 40%, 60%, and 80% of maximal inspiratory pressure) to compare their acute effects on these variables. This graded loading approach will allow identification of the optimal dose capable of maximizing diaphragmatic neuromuscular activation without inducing early fatigue, leveraging the post-activation potentiation phenomenon to improve respiratory efficiency and swimming performance.

Device: POWERbreath

IMT: 60%

EXPERIMENTAL

The study will apply four respiratory warm-up intensities (15%, 40%, 60%, and 80% of maximal inspiratory pressure) to compare their acute effects on these variables. This graded loading approach will allow identification of the optimal dose capable of maximizing diaphragmatic neuromuscular activation without inducing early fatigue, leveraging the post-activation potentiation phenomenon to improve respiratory efficiency and swimming performance.

Device: POWERbreath

IMT: 80%

EXPERIMENTAL

The study will apply four respiratory warm-up intensities (15%, 40%, 60%, and 80% of maximal inspiratory pressure) to compare their acute effects on these variables. This graded loading approach will allow identification of the optimal dose capable of maximizing diaphragmatic neuromuscular activation without inducing early fatigue, leveraging the post-activation potentiation phenomenon to improve respiratory efficiency and swimming performance.

Device: POWERbreath

Interventions

It is a crossover study in which the different exercise intensities are investigated.

IMT: 15%IMT: 60%IMT: 80%IMT:40%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 19, 2026

First Posted

May 19, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 19, 2026

Record last verified: 2026-02