Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 5:58 PM
Study NCT ID:
NCT06121128
Status:
UNKNOWN
Last Update Posted:
2023-11-07
First Post:
2023-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000532', 'term': 'Altitude Sickness'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial (RCT): with a Female Control Group (FCON), a Male Control Group (MCON), a Female Training Group (FTRAIN), a Male Training Group (MTRAIN)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-05', 'studyFirstSubmitDate': '2023-10-30', 'studyFirstSubmitQcDate': '2023-11-05', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sex-differences', 'timeFrame': 'One week prior and in the week immediately following the intervention', 'description': 'Primary objective:\n\nTo assess the change of a time limit duration in ergocycle after 4 weeks of inspiratory muscle training (IMT) between males and females.'}, {'measure': 'Effect in hypoxia', 'timeFrame': 'One week prior and in the week immediately following the intervention', 'description': 'Secondary objective:\n\nTo assess the change of a time limit duration in ergocycle after 4 weeks of inspiratory muscle training (IMT) between hypoxia and normoxia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypoxia, Altitude']}, 'descriptionModule': {'briefSummary': 'The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance.\n\nIntervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening.\n\nResistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.\n\nFour laboratory visits: 2 pre-tests and 2 post-tests. Each pre- / post- test will go under normoxic and hypoxic conditions.\n\nMeasurements include Pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. VO2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)', 'detailedDescription': 'The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance.\n\nIntervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening.\n\nResistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.\n\nFour laboratory visits: 2 pre-tests and 2 post-tests. Each pre- / post- test will go under normoxic and hypoxic conditions.\n\nMeasurements include Pulmonary functions (spirometry test); blood microcirculation (vascular occlusion test); gas exchanges (e.g. VO2max), cardiac parameters, heart rate variability, maximal aerobic power (incremental and time limit test)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion: endurance trained athletes between 18 and 44 years old\n\nExclusion Criteria:\n\ncardiovascular, metabolic and respiratory diseases, smoking history, prescription medication (Two medication families are known to interfere with FC:\n\n* Calcium channel blockers\n* Beta-blockers\n\nTwo families are known to interfere during spirometry measurements:\n\n* Inhaled beta-agonists\n* Inhaled glucocorticoids)'}, 'identificationModule': {'nctId': 'NCT06121128', 'acronym': 'RespiPerf', 'briefTitle': 'The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne'}, 'officialTitle': 'The Effects of Inspiratory Muscle Training on Endurance Performance in Trained Athletes Under Normoxic and Hypoxic Conditions: A Gender-based Comprehensive Study', 'orgStudyIdInfo': {'id': '2023-01638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Female Control Group (FCON)', 'description': 'female endurance trained athletes between 18 and 44 years old', 'interventionNames': ['Procedure: Normal Breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Female Training Group (FTRAIN)', 'description': 'female endurance trained athletes between 18 and 44 years old', 'interventionNames': ['Procedure: Inspiratory Muscle Training (IMT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Male Control Group (MCON)', 'description': 'male endurance trained athletes between 18 and 44 years old', 'interventionNames': ['Procedure: Normal Breathing']}, {'type': 'EXPERIMENTAL', 'label': 'Male Training Group (MTRAIN)', 'description': 'male endurance trained athletes between 18 and 44 years old', 'interventionNames': ['Procedure: Inspiratory Muscle Training (IMT)']}], 'interventions': [{'name': 'Inspiratory Muscle Training (IMT)', 'type': 'PROCEDURE', 'otherNames': ['IMT'], 'description': 'The POWERbreathe™ Plus: an Inspiratory Muscle Training device (IMT) with adjustable resistance.\n\nIntervention lasts 4 weeks, with a frequency of 6 days/week, 2 series of 30 inspirations in the morning and evening.\n\nResistance based on 60% of the Pressure Maximal Inspiratory (PMI). Progressive increase in resistance every week.', 'armGroupLabels': ['Female Training Group (FTRAIN)', 'Male Training Group (MTRAIN)']}, {'name': 'Normal Breathing', 'type': 'PROCEDURE', 'description': 'No IMT performed', 'armGroupLabels': ['Female Control Group (FCON)', 'Male Control Group (MCON)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof Ordinaire', 'investigatorFullName': 'Gregoire Millet', 'investigatorAffiliation': 'University of Lausanne'}}}}