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Clinical Trials/NCT07379060
NCT07379060
Active, not recruiting
Not Applicable

Pilot Study to Evaluate a Non-invasive Training System for Inspiratory Muscles in Athletic Women

University of Vigo1 site in 1 country21 target enrollmentStarted: September 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
University of Vigo
Enrollment
21
Locations
1
Primary Endpoint
Power breath. Maximum Inspiratory Pressure

Overview

Brief Summary

The goal of this clinical trial is to study whether there are significant differences between the control and experimental groups in terms of the improvement in lung function of the athletes who have performed Inspiratory muscle training with powerbreath. The main question it aims to answer is:

• the study that power breath is effective in providing improvements in inspiratory muscle strength, lung function, exercise capacity, quality of life, analytical parameters, dyspnea, fatigue and activities of daily living and impacting their sporting success.

Researchers will compare specific powerbreath training with nettraining period without this device.

Participants will:

  • Perform regular sports training along with powerbreath training for 10 weeks
  • A washout period of two months
  • Perform regular sports training for 10 weeks

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Female athletes from the Galician Center for Sports Technification (CGTD) in the city of Pontevedra.
  • Sign the informed consent document.
  • Possession of the mental capacity required to participate in the study

Exclusion Criteria

  • Age below the legal healthcare age (16 years).
  • Lack of skills necessary to operate the no invasive device

Arms & Interventions

Training routine and additionally perform Inspiratory Muscle Training 1

Experimental

The experimental 1 group will follow their regular training routine and additionally perform Inspiratory Muscle Training using the PwB Medic Plus device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks

Intervention: Inspiratory Muscle Training 1 (Device)

Training routine and additionally perform Inspiratory Muscle Training 2

Experimental

The experimental 2 group will follow their regular training routine and additionally perform Inspiratory Muscle Training using the PwB Medic Plus device. This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure. The intervention will last for 10 weeks

Intervention: Inspiratory Muscle Training 2 (Device)

Normal Training routine 1

No Intervention

Normal Training routine 1

Normal Training routine 2

No Intervention

Normal Training routine 2

Outcomes

Primary Outcomes

Power breath. Maximum Inspiratory Pressure

Time Frame: From enrollment to the end of treatment at 10 weeks

This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Vigo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rocío Abalo

Principal investigator

University of Vigo

Study Sites (1)

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