Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT06375720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons 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': 350}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-04-16', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Sleep quality'}, {'measure': '12-Item Short Form Health Survey', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'General health'}, {'measure': 'Blood glucose metabolism index', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'fasting blood glucose'}, {'measure': 'Blood lipid metabolism index', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'total cholesterol (TC); total triglyceride (TG); low density lipoprotein (LDL);high density lipoprotein (HDL)'}, {'measure': 'functional Magnetic Resonance Imaging', 'timeFrame': '12 weeks or 24 weeks [post-intervention]', 'description': 'functional Magnetic Resonance Imaging'}, {'measure': 'Electroencephalogram', 'timeFrame': '12 weeks or 24 weeks [post-intervention]', 'description': '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.'}, {'measure': 'Heart rate variability', 'timeFrame': '12 weeks or 24 weeks [post-intervention]', 'description': 'Cardiac autonomic modulations'}, {'measure': 'Gut microflora', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': '16S rRNA amplification sequencing was used to detect intestinal microbiota.'}], 'primaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': '12 weeks, 24 weeks', 'description': 'Global cognition'}], 'secondaryOutcomes': [{'measure': 'Montreal Cognitive Assessment', 'timeFrame': '52 weeks', 'description': 'Global cognition'}, {'measure': 'Wechsler Memory Scale', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Memory function'}, {'measure': 'Digit Symbol Substitution Test', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Attention'}, {'measure': 'Trial Making Test part B', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Executive Function'}, {'measure': 'Stroop Color Word Test', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Processing Speed'}, {'measure': 'Boston Naming Test', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Verbal fluency'}, {'measure': 'Rey-Osterrieth Complex Graphics Test', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Visuo-spatial ability'}, {'measure': 'Rey Auditory Verbal Learning Test', 'timeFrame': '12 weeks, 24 weeks and 52 weeks', 'description': 'Episodic memory'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tai Chi Chuan', 'Cognitive Function'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment.', 'detailedDescription': 'Mild cognitive impairment (MCI) is regarded as a prodrome to dementia and affects 16% to 20% of people aged older than 65 years. Tai Chi Chuan is an increasingly popular multi-modal physical and mental exercise. Studies have shown that Tai Chi Chuan can effectively improve the cognitive function of elderly persons with MCI. However, the relationship between the effects of different frequencies and duration of Tai Chi Chuan to improve the cognitive function of elderly persons with MCI is not yet clear. The purpose of this study is to determine the optimal frequency and duration of Tai Chi Chuan. The investigators will conduct a single-blind, randomized controlled trial in 350 persons who meet the presence of MCI without dementia. Persons will be randomly assigned to either the Tai Chi Chuan intervention group once or twice a week for 12 or 24 weeks, or the health education control group once every four weeks for 24 weeks. All groups will be followed for 52 weeks.'}, '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 Chuan 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': 'NCT06375720', 'briefTitle': 'Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Fujian University of Traditional Chinese Medicine'}, 'officialTitle': 'Dose-effect of Different Frequencies and Duration of Tai Chi Chuan to Improve Cognitive Function in Persons With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': 'FujianUTCM-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group1', 'description': '12 weeks of Tai Chi Chuan, 3x/week', 'interventionNames': ['Behavioral: Lower frequency, shorter period of Tai Chi Chuan']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group2', 'description': '12 weeks of Tai Chi Chuan, 5x/week', 'interventionNames': ['Behavioral: Higher frequency, shorter period of Tai Chi Chuan']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group3', 'description': '24 weeks of Tai Chi Chuan, 3x/week', 'interventionNames': ['Behavioral: Lower frequency, longer period of Tai Chi Chuan']}, {'type': 'EXPERIMENTAL', 'label': 'Tai Chi Chuan Group4', 'description': '24 weeks of Tai Chi Chuan, 5x/week', 'interventionNames': ['Behavioral: Higher frequency, longer period of Tai Chi Chuan']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Participants would take standard health education 0.5hour/ session, 2 sessions/month for 6 months.', 'interventionNames': ['Behavioral: Standard Health Education']}], 'interventions': [{'name': 'Lower frequency, shorter period of Tai Chi Chuan', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.', 'armGroupLabels': ['Tai Chi Chuan Group1']}, {'name': 'Higher frequency, shorter period of Tai Chi Chuan', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 12 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.', 'armGroupLabels': ['Tai Chi Chuan Group2']}, {'name': 'Lower frequency, longer period of Tai Chi Chuan', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.', 'armGroupLabels': ['Tai Chi Chuan Group3']}, {'name': 'Higher frequency, longer period of Tai Chi Chuan', 'type': 'BEHAVIORAL', 'description': 'Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 5 sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard health education 0.5 hour/session, 2 sessions/month for 6 months.', 'armGroupLabels': ['Tai Chi Chuan Group4']}, {'name': 'Standard Health Education', 'type': 'BEHAVIORAL', 'description': 'Participants would take standard health education 0.5 hour/ session, 2 sessions/month for 6 months.', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lidian Chen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Third Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Fujian University of Traditional Chinese Medicine', 'investigatorFullName': 'Lidian Chen', 'investigatorAffiliation': 'Fujian University of Traditional Chinese Medicine'}}}}