Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:16 PM
Study NCT ID:
NCT07379060
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Training of the Inspiratory Muscles in Athletic Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Power breath. Maximum Inspiratory Pressure', 'timeFrame': 'From enrollment to the end of treatment at 10 weeks', 'description': 'This training consists of 30 breaths, twice daily, with a resistance load set between 40% and 60% of their Maximum Inspiratory Pressure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Muscles']}, 'descriptionModule': {'briefSummary': '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:\n\n• 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.\n\nResearchers will compare specific powerbreath training with nettraining period without this device.\n\nParticipants will:\n\n* Perform regular sports training along with powerbreath training for 10 weeks\n* A washout period of two months\n* Perform regular sports training for 10 weeks'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female athletes from the Galician Center for Sports Technification (CGTD) in the city of Pontevedra.\n* Sign the informed consent document.\n* Possession of the mental capacity required to participate in the study\n\nExclusion Criteria:\n\n* Age below the legal healthcare age (16 years).\n* Lack of skills necessary to operate the no invasive device'}, 'identificationModule': {'nctId': 'NCT07379060', 'briefTitle': 'Non-invasive Training of the Inspiratory Muscles in Athletic Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Vigo'}, 'officialTitle': 'Pilot Study to Evaluate a Non-invasive Training System for Inspiratory Muscles in Athletic Women', 'orgStudyIdInfo': {'id': 'CEIm 2562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training routine and additionally perform Inspiratory Muscle Training 1', 'description': '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', 'interventionNames': ['Device: Inspiratory Muscle Training 1']}, {'type': 'EXPERIMENTAL', 'label': 'Training routine and additionally perform Inspiratory Muscle Training 2', 'description': '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', 'interventionNames': ['Device: Inspiratory Muscle Training 2']}, {'type': 'NO_INTERVENTION', 'label': 'Normal Training routine 1', 'description': 'Normal Training routine 1'}, {'type': 'NO_INTERVENTION', 'label': 'Normal Training routine 2', 'description': 'Normal Training routine 2'}], 'interventions': [{'name': 'Inspiratory Muscle Training 1', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Training routine and additionally perform Inspiratory Muscle Training 1']}, {'name': 'Inspiratory Muscle Training 2', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Training routine and additionally perform Inspiratory Muscle Training 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36005', 'city': 'Pontevedra', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Faculty of Physiotherapy', 'geoPoint': {'lat': 42.431, 'lon': -8.64435}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vigo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rocío Abalo', 'investigatorAffiliation': 'University of Vigo'}}}}