Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT04463732
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005080', 'term': 'Exercise Test'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D016552', 'term': 'Ergometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm and Sternocleidomastoid muscle activation', 'timeFrame': 'during the loaded inspiratory muscle test condition; it would take about 3 minutes', 'description': 'Root mean square values'}, {'measure': 'Maximal exercise capacity', 'timeFrame': 'during the cardiopulmonary exercise test; it would take about 12 to 15 minutes', 'description': 'Maximal oxygen consumption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Maximal oxygen consumption, VO2max, is the gold standard to evaluate human aerobic fitness, which stands for the maximal capacity of cardiorespiratory system and musculoskeletal system to transport and utilize oxygen. Previous study showed that there is significant correlation between maximal oxygen consumption from cardiopulmonary exercise test and strength and endurance of lower extremities. In people with sedentary lifestyle, they often limited by the lower limb muscle performance during cardiopulmonary exercise test. Their breathing patterns are more irregular than athletes during cardiopulmonary exercise test. However, there is no study comparing the activation pattern of respiratory muscles between these two groups. Whether the breathing pattern in people with lower exercise capacity is less efficient under exertional activities still unknown. The purpose of this study is to investigate the relationship between maximal oxygen consumption and inspiratory muscle activation pattern in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy population is free from abnormal breathing pattern caused by disease. Their terminals of cardiopulmonary exercise test are not limited by symptoms of disease.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults (age \\> 20 years old)\n* Be able to cooperate with the measurements of this study\n\nExclusion Criteria:\n\n* any clinical diagnosis that will influence the measurement, including any history of neuromyopathy\n* angina, acute myocardial infarction in the previous one month\n* pregnancy\n* history of syncope during exercise\n* any musculoskeletal system disorder that unable to perform cardiopulmonary exercise test'}, 'identificationModule': {'nctId': 'NCT04463732', 'briefTitle': 'The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'The Relationship Between Maximal Oxygen Consumption and Inspiratory Muscle Activation Pattern Under Loaded Inspiratory Muscle Tests in Healthy Adults', 'orgStudyIdInfo': {'id': '202005050RINA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy group', 'description': 'Subjects are above 20 years old. Their condition is healthy with no history of inspiratory disease. They can cooperate with the measurements of this study.', 'interventionNames': ['Other: Loaded inspiratory muscle test and cardiopulmonary exercise test']}], 'interventions': [{'name': 'Loaded inspiratory muscle test and cardiopulmonary exercise test', 'type': 'OTHER', 'description': 'This is an observational study. Loaded inspiratory muscle test is setting at 30% of maximal inspiratory pressure. Subjects will perform only 15 breaths under this intensity to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training. Cardiopulmonary exercise test is performed by using bicycle ergometer. These two tests will be performed at least 1 week separately.', 'armGroupLabels': ['Healthy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Zhongzheng Dist', 'country': 'Taiwan', 'facility': 'School and Graduate Institute of Physical Therapy of National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Li-Ying Wang, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}