Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-01 @ 2:31 PM
Study NCT ID:
NCT05655559
Status:
UNKNOWN
Last Update Posted:
2022-12-19
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of Patient-Reported Dyspnea and Fatigue', 'timeFrame': 'Baseline', 'description': 'Measurement of dyspnea during submaximal exercise with The Modified Borg Dyspnea Scale (MBS).'}, {'measure': 'Measurement of Muscle Oxygenation', 'timeFrame': 'Baseline', 'description': 'Measurement of muscle oxygenation with Moxy Monitor.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle oxygenation', 'treadmill', 'cycle', 'moxy', 'exercise'], 'conditions': ['Muscle Oxygenation', 'Treadmill']}, 'descriptionModule': {'briefSummary': 'The study will be conducted on healthy young adults. Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), including muscle oxygenation, will be compared in treadmill and bicycle exercises.', 'detailedDescription': 'In recent studies, sensor systems that measure the oxygen level in muscle tissue at the microvascular level have been developed. These devices working with Near Infrared Spectroscopy (NIRS, 630-850 nm) method; It provides measurements of muscle oxygenation level at rest and during exercise. It is known that significant changes in vastus lateralis oxygenation levels measured by the NIRS method are associated with various factors such as exercise intensity, exercise profile and training. The aim of this study is to measure the oxygenation level of the vastus lateralis muscle during the exercises performed on the treadmill and bicycle ergometer, and thus to reveal the effect of using different ergometers on fatigue and sportive performance.\n\nMuscle oxygen levels will be measured and evaluated before, during and after exertion. In addition, blood pressure (BP), oxygen saturation (SpO2), dyspnea and fatigue parameters will be recorded and evaluated. If undesirable symptoms are observed during our study, the exercise will be terminated. Within the scope of the project, the acute effect will be examined with the measurements made with the Moxy device on the vastus lateralis muscle during the treadmill and bicycle ergonometer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteering to participate in the study\n* No known disease\n* Be between the ages of 18-25\n\nExclusion Criteria:\n\n* Having cardiopulmonary disease,\n* Have had lower extremity muscle or joint injuries\n* Having an orthopedic/neurological disorder\n* Smoking and alcohol use,\n* Have suffered a lower extremity muscle or joint injury,\n* Having an orthopedic/neurological disorder,\n* Uncontrollable asthma,\n* PaO2\\< 50 mmHg,\n* PaCO2\\> 70mmHg,\n* Individuals with a resting systolic blood pressure of 200 mmHg'}, 'identificationModule': {'nctId': 'NCT05655559', 'briefTitle': 'Muscle Oxygenation in Treadmill and Cycle Ergometer Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Comparison of Oxygenation of the Vastus Lateralis Muscle During Cycling and Treadmill Exercises', 'orgStudyIdInfo': {'id': 'Muscle_oxygenation'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treadmill Group', 'description': 'Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during treadmill exercises.', 'interventionNames': ['Other: Questionnare', 'Device: Moxy Muscle Oxygen Monitor']}, {'type': 'EXPERIMENTAL', 'label': 'Cycle Group', 'description': 'Hemodynamic effects such as heart rate, blood pressure, oxygen saturation (SpO2), dyspnea and fatigue including muscle oxygenation, will be compared during cycling exercises.', 'interventionNames': ['Other: Questionnare', 'Device: Moxy Muscle Oxygen Monitor']}], 'interventions': [{'name': 'Questionnare', 'type': 'OTHER', 'description': 'Measurement of Dyspnea and Fatigue during submaximal exercise with The Modified Borg Scale (MBS).', 'armGroupLabels': ['Cycle Group', 'Treadmill Group']}, {'name': 'Moxy Muscle Oxygen Monitor', 'type': 'DEVICE', 'description': 'Measurement of muscle oxygenation with Moxy Muscle Oxygen Monitor.', 'armGroupLabels': ['Cycle Group', 'Treadmill Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Esra PEHLİVAN, Assoc. Prof.', 'role': 'CONTACT', 'email': 'esra.pehlivan@sbu.edu.tr', 'phone': '0216 346 36 36', 'phoneExt': '2015'}, {'name': 'Dilara KALAYCI', 'role': 'CONTACT', 'email': 'dilarakalayyci@gmail.com'}], 'overallOfficials': [{'name': 'Esra PEHLİVAN, Assoc. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}