Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-01 @ 9:12 PM
Study NCT ID:
NCT06372535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2024-03-18', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Blood glucose metabolism index', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks', 'description': 'fasting blood glucose'}, {'measure': 'Blood lipid metabolism index', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks', 'description': 'total cholesterol (TC), total triglyceride (TG), low density lipoprotein (LDL), high density lipoprotein (HDL)'}, {'measure': 'Functional Magnetic Resonance Imaging', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention]', 'description': 'Functional Magnetic Resonance Imaging'}, {'measure': 'Electroencephalogram', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention]', 'description': '1. Resting-State Electroencephalogram (EEG) Power Spectrum Changes. The power spectrum density of the brain in a relaxed state is measured using a resting-state electroencephalogram (EEG) for the delta (1-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), beta (13-30 Hz), and gamma (30-100 Hz) bands. Changes in the power of these frequency bands before and after the intervention are assessed to reflect changes in the level of brain activity.\n2. Task-Related Brain Electrophysiological Activity While performing specific cognitive tasks, brain activity is recorded using an Electroencephalogram (EEG), and task-related EEG event-related potentials are analyzed.'}, {'measure': 'Heart rate variability', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention]', 'description': 'cardiac autonomic modulations'}, {'measure': 'Gut microflora', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks', 'description': '16S rRNA amplification sequencing will be used to detect intestinal microbiota. Stool sample from each sub center will be stored within 1 h of collection at - 80 °C freezer. Subsequently, the fecal samples will be stored in dry ice and transported in batches to the laboratory within 8 hours, followed by storage in - 80 °C freezer.'}, {'measure': 'Sleep Quality', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks', 'description': 'The Pittsburgh Sleep Quality Index will be used to evaluate sleep quality, with a total score of 0-21. The higher the score, the poorer the sleep quality.'}, {'measure': 'General health', 'timeFrame': '8 weeks or 16 weeks or 24 weeks [post-intervention] and 52weeks', 'description': "12-Item Short Form Health Survey will be used to evaluate general health. the higher the total score, the better the individual's health status."}], 'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': '8 weeks, 16 weeks, 24 weeks', 'description': 'Global cognition'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': '52 weeks', 'description': 'Global cognition'}, {'measure': 'Wechsler Memory Scale', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Memory function'}, {'measure': 'Digital Symbol test', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Attention'}, {'measure': 'Trial Making Test part B', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Executive function'}, {'measure': 'Stroop color word test', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Processing speed'}, {'measure': 'Boston naming test', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Verbal fluency'}, {'measure': 'Rey-Osterrieth complex graphics test', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Rey-Osterrieth complex graphics test'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': '8 weeks[the duration of intervention arm greater than or equal 8 weeks], 16 weeks [the duration of intervention arm greater than or equal 16 weeks], 24 weeks [the duration of intervention arm is 24 weeks] and 52 weeks', 'description': 'Episodic memory'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tai Chi Chuan', 'Cognitive Function', 'Dose-response'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'To determine the impact of Tai Chi Chuan with different exercise volume on cognitive function in elderly patients with mild cognitive impairment.', 'detailedDescription': 'Taking MCI as a potential gateway, early intervention to delay the occurrence of dementia has become an important consensus in this field. Exercise is an important means to improve cognitive function in MCI, but the effect of exercise is influenced by the dosage. Tai Chi Chuan, is a moderate intensity aerobic exercise. Previous studies by our team and others had confirmed its effect on cognitive function in MCI. However, the dose parameters of Tai Chi Chuan exercise varied in these studies, and the dose-response relationship is still unclear. The purpose of this study is to explore the dose-response relationship between different volume of Tai Chi Chuan exercise and cognitive function（global cognition and cognition of subdomains）in elderly MCI patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Presence of mild cognitive impairment, not demented;\n2. Age ≥ 60 years old;\n3. Informed consent and voluntary participation.\n\nExclusion Criteria:\n\n1. Geriatric Depression Scale score ≥ 9 points\n2. Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;\n3. Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;\n4. Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;\n5. Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;\n6. Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);\n7. Participating in other experiments that influence this study;\n8. Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time."}, 'identificationModule': {'nctId': 'NCT06372535', 'briefTitle': 'Effects of Tai Chi Chuan With Different Doses on Cognitive Function in Elderly Patients With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Fujian University of Traditional Chinese Medicine'}, 'officialTitle': 'Dose-Response Effects of Tai Chi Chuan Interventions on Cognitive Function in Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'FujianUTCM-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group1', 'description': 'Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 1）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group2', 'description': 'Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 2）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group3', 'description': 'Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 3）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group4', 'description': 'Tai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 4）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group5', 'description': 'Tai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 5）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group6', 'description': 'Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 6）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group7', 'description': 'Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 7）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group8', 'description': 'Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 8）']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group9', 'description': 'Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks.', 'interventionNames': ['Behavioral: Tai Chi Chuan （dose 9）']}], 'interventions': [{'name': 'Tai Chi Chuan （dose 1）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 8 weeks.\n\nThere were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group1']}, {'name': 'Tai Chi Chuan （dose 2）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 16 weeks.\n\nThere were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group2']}, {'name': 'Tai Chi Chuan （dose 3）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 0.5 hour/session, 5 sessions/week for 24 weeks.\n\nThere were 10 minutes warm-up, 30 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group3']}, {'name': 'Tai Chi Chuan （dose 4）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 8 weeks.\n\nThere were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group4']}, {'name': 'Tai Chi Chuan （dose 5）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 16 weeks.\n\nThere were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group5']}, {'name': 'Tai Chi Chuan （dose 6）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks.\n\nThere were 10 minutes warm-up, 60 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group6']}, {'name': 'Tai Chi Chuan （dose 7）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 8 weeks.\n\nThere were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group7']}, {'name': 'Tai Chi Chuan （dose 8）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 16 weeks.\n\nThere were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group8']}, {'name': 'Tai Chi Chuan （dose 9）', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1.5 hour/session, 5 sessions/week for 24 weeks.\n\nThere were 10 minutes warm-up, 90 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training.', 'armGroupLabels': ['Tai Chi Chuan Group9']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lidian Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Third Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Lidian Chen', 'investigatorAffiliation': 'Fujian University of Traditional Chinese Medicine'}}}}