- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379060
Non-invasive Training of the Inspiratory Muscles in Athletic Women
Pilot Study to Evaluate a Non-invasive Training System for Inspiratory Muscles in Athletic Women
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pontevedra
-
Pontevedra, Pontevedra, Spain, 36005
- Faculty of Physiotherapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training routine and additionally perform Inspiratory Muscle Training 1
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
|
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
|
|
Experimental: Training routine and additionally perform Inspiratory Muscle Training 2
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
|
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
|
|
No Intervention: Normal Training routine 1
|
|
|
No Intervention: Normal Training routine 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment to the end of treatment at 10 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CEIm 2562
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Muscles
-
Onze Lieve Vrouw HospitalCompletedRespiratory Muscles | ElectromyographyBelgium
-
University of Health Sciences LahoreActive, not recruitingWaist Circumference | Abdominal Muscles Strength | Abdominal Muscles Endurance | Abdominal Muscles FlexibilityPakistan
-
Gazi UniversityT.C. Dumlupınar ÜniversitesiCompletedRespiratory Muscles and Core StabilizationTurkey
-
Scarlata, Simone, M.D.CompletedUltrasonography | Respiratory Muscles | Diaphragm | Osteopathic Medicine
-
Duke UniversityCase Western Reserve UniversityCompleted
-
Medipol UniversityRecruitingCardiorespiratory Fitness | Respiratory MusclesTurkey
-
University of SalamancaColegio Profesional de Fisioterapeutas de Castilla y LeónCompleted
-
European University of MadridCompletedPelvic Floor | Abdominal Muscles | Abdominal Muscles/ultrasonographySpain
-
Christiana Care Health ServicesCompletedAbdominal MusclesUnited States
-
Pamukkale UniversityUnknownFlexibility | Hamstring MusclesTurkey
Clinical Trials on Inspiratory Muscle Training 1
-
Ceren Derya GültekinRecruitingPulmonary Rehabilitation | Inspiratory Muscle Training | Hematopoietic Stem Cell Transplantation (HSCT)Turkey
-
Elisabethinen HospitalUnknownStem Cell Transplantation | Inspiratory Muscle Training | Respiratory Muscle TrainingAustria
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Istinye UniversityCompletedStroke | Respiratory MusclesTurkey
-
Dokuz Eylul UniversityDokuz Eylül University, Scientific Research Projects Coordination UnitCompleted
-
University of British ColumbiaNatural Sciences and Engineering Research Council, CanadaCompletedRespiratory Muscles | Breathing ExercisesCanada
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Universidad Francisco de VitoriaActive, not recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric HealthSpain
-
King Saud UniversityCompleted
-
Hong Kong Metropolitan UniversityNot yet recruiting