Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 5:58 PM
Study NCT ID:
NCT06638359
Status:
COMPLETED
Last Update Posted:
2024-10-15
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Moderate Exercise And Interval Exercise On Sleep Quality
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-01', 'size': 573237, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-02T03:17', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'control trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-09', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-10-09', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'total sleep time', 'timeFrame': 'Day 1', 'description': 'total sleep time on Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart rate variability', 'sleep quality'], 'conditions': ['Exercise Addiction', 'Control Condition']}, 'descriptionModule': {'briefSummary': 'This study aimed to explore the effects of a single bout of moderate- aerobic continuous exercise (MACE) and high-intensity intermittent exercise (HIIE) on sleep during continuous night shifts in medical shift workers with mild sleep impairment.', 'detailedDescription': 'Medical staff with sleep disturbances due to their night-shift work were randomized to either a treadmill walking session for 47 minutes with moderate intensity (the heart rate reaches 70\\~75% of the maximum heart rate), treadmill running section for 28 minutes with intermittent high-intensity (the heart rate reaches 90\\~95% of the maximum heart rate for 4 minutes and 50\\~70% for 3 minutes), or a quiet-rest control, 14 hours before undertaking a continuous night shift. Sleep quality was assessed by ActiGraph with subjective questionnaire for 1 night and 3 nights after exercise. Tests were performed (t-tests or χ2 tests) to test for differences between any two of the three intervention trials.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* medical staff who have worked at least three consecutive night shifts\n* reporting sleep disturbed during the night shift\n* not taking sleep/psychotropic medications\n* no clinical diagnosis of sleep apnea or other sleep disorder\n* not exercising regularly\n\nExclusion Criteria:\n\n* not medical staff\n* without night shift\n* taking sleep/psychotropic medications\n* exercising regularly'}, 'identificationModule': {'nctId': 'NCT06638359', 'acronym': 'EX&sleep', 'briefTitle': 'Effects of Moderate Exercise And Interval Exercise On Sleep Quality', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan Sport University'}, 'officialTitle': 'Effects of an Acute Bout of Moderate-Intensity Aerobic Exercise And High-Intensity Intermittent Exercise On Sleep During Night Shifts In Medical Shift Workers With Sleep Impairment: A Single-Blind Crossover Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '113-6'}, 'secondaryIdInfos': [{'id': '113-3', 'type': 'OTHER', 'domain': 'NTUS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise', 'description': 'moderate intensity or interval exercise', 'interventionNames': ['Behavioral: moderate exercise', 'Behavioral: interval exercise', 'Behavioral: Control (placebo) group']}, {'type': 'SHAM_COMPARATOR', 'label': 'control', 'description': 'without exercise', 'interventionNames': ['Behavioral: moderate exercise', 'Behavioral: interval exercise', 'Behavioral: Control (placebo) group']}], 'interventions': [{'name': 'moderate exercise', 'type': 'BEHAVIORAL', 'description': 'moderate exercise for 47 minutes', 'armGroupLabels': ['control', 'exercise']}, {'name': 'interval exercise', 'type': 'BEHAVIORAL', 'description': 'interval exercise for 28 minutes', 'armGroupLabels': ['control', 'exercise']}, {'name': 'Control (placebo) group', 'type': 'BEHAVIORAL', 'description': 'without exercise', 'armGroupLabels': ['control', 'exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'state': 'North', 'country': 'Taiwan', 'facility': 'National Taiwan University of Sport', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Sport research center', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University of Sport'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan Sport University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chih-Hui Chiu', 'investigatorAffiliation': 'National Taiwan Sport University'}}}}