Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT06245850
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-01-30', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HAMD score', 'timeFrame': '8 weeks', 'description': 'HAMD score: The Hamilton Depression Scale (HAMD) were used to evaluate the depression level of the subjects. The HAMD-17 score is 0-6 points for no depression, 8 7-17 points for mild depression, 18-24 points for moderate depression, and 25-54 points for severe depression. A higher score corresponds to more severe depression.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Patients and their families all agreed .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Conformity to the diagnostic criteria for stroke in the \\"Diagnostic Essentials of Various Cerebrovascular Diseases\\" revised by the Fourth National Cerebrovascular Academic Conference, and confirmed by cranial CT or MRI.\n2. The course of stroke was 2 weeks to 6 months, with steady conditions and stable vital signs.\n3. The age ranged from 30 to 80 years old, with at least a junior high school education.\n4. The patients had no serious intellectual, language comprehension and behavioral disorders, and could complete the assessment of scales.\n5. Achieving a sitting balance of at least reaches level 3, Brunnstrom stage IV or above, and being able to complete Baduanjin training.\n6. The National Institutes of Health Stroke Scale (NIHSS) ≤ 15 points.\n7. Conforming to the diagnostic criteria for depression in the \\"Chinese Experts Consensus on Clinical Practice of Post-Stroke Depression\\".\n\nExclusion Criteria:\n\nThe exclusion criteria:\n\n1. Disturbance of consciousness, unable to cooperate with polysomnography (PSG) and scale evaluators.\n2. Pre-existing diagnosis of depression before stroke.\n3. Severe pre-existing sleep disorders before stroke.\n4. Patients with mental illness, immune system disorders, severe liver and kidney dysfunction, and severe cardiopulmonary dysfunction'}, 'identificationModule': {'nctId': 'NCT06245850', 'acronym': 'ZZU', 'briefTitle': 'Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression', 'organization': {'class': 'OTHER', 'fullName': 'Zhengzhou University'}, 'officialTitle': 'Impact of Baduanjin Exercise Combined With Rational Emotive Behavior Therapy on Sleep and Mood in Patients With Post-stroke Depression: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Zhengzhouuniversity'}, 'secondaryIdInfos': [{'id': '82071331', 'type': 'OTHER_GRANT', 'domain': 'National Natural Science fouding'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baduanjin Group', 'interventionNames': ['Behavioral: Baduanjin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'REBTgroup', 'interventionNames': ['Behavioral: Rational emotive behavior therapy']}], 'interventions': [{'name': 'Baduanjin', 'type': 'BEHAVIORAL', 'description': 'chinese baduanjin', 'armGroupLabels': ['Baduanjin Group']}, {'name': 'Rational emotive behavior therapy', 'type': 'BEHAVIORAL', 'description': 'Rational emotive behavior therapy', 'armGroupLabels': ['REBTgroup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Henan', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Liu Yihan', 'investigatorAffiliation': 'Zhengzhou University'}}}}