NCT07379060

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress91%
Sep 2025Jun 2026

Study Start

First participant enrolled

September 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 3, 2026

Status Verified

November 1, 2025

Enrollment Period

8 months

First QC Date

January 22, 2026

Last Update Submit

January 30, 2026

Conditions

Respiratory Muscles

Outcome Measures

Primary Outcomes (1)

  • Power breath. Maximum Inspiratory Pressure

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

    From enrollment to the end of treatment at 10 weeks

Study Arms (4)

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

Device: Inspiratory Muscle Training 1

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

Device: Inspiratory Muscle Training 2

Normal Training routine 1

NO INTERVENTION

Normal Training routine 1

Normal Training routine 2

NO INTERVENTION

Normal Training routine 2

Interventions

Inspiratory Muscle Training 1DEVICE

Inspiratory Muscle Training using the no invasive 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

Training routine and additionally perform Inspiratory Muscle Training 1
Inspiratory Muscle Training 2DEVICE

Inspiratory Muscle Training using the no invasive 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

Training routine and additionally perform Inspiratory Muscle Training 2

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy

Pontevedra, Pontevedra, 36005, Spain

Location

Study Design

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

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

September 15, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 3, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)