Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT01724151
Status:
COMPLETED
Last Update Posted:
2014-04-22
First Post:
2010-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise Training in Patients With Mild Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2012-11-06', 'lastUpdatePostDateStruct': {'date': '2014-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Walking speed of participants', 'timeFrame': '1 hour', 'description': 'Subjects walk through 10m walkway with steady comfortable pace. We record complete duration and calculate walking speed (m/sec)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', "Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The proposes of this study are\n\n1. To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.\n2. To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment, the capability of activity and social engagement (including quality of life).\n3. To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of the patients with cognitive impairment.\n\nThe study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.', 'detailedDescription': 'There is already evidence that exercise training can delay the progression of dementia. But if the same effect could be seen in patients with cognitive impairment remains unknown. There is an increasing importance of how to delay or prevent the turn over of cognitive impairment patients into dementia in recent years. Thus we propose to investigate the following issues.\n\n1. To understand the physical activities of patients with cognitive impairment in Taiwan and construct the validity and reliability of the physical activity questionnaire and actigram in this population.\n2. To understand the relation between brain structure (brain tractography and resting state functional MRI) and cognitive and physical functions of patients with cognitive impairment , the capability of activity and social engagement (including quality of life).\n3. To understand the efficacy of exercise on the brain structure (brain tractography and resting state functional MRI), cognitive and physical functions, the capability of activity and social engagement (including quality of life) of patients with cognitive impairment.\n\nThe study is a cross sectional study. We recruited 40 cognitive impairment patients from the memory clinic at National Taiwan University Hospital and another 20 healthy controls matched for age and gender. We collected the actigram and physical activity from questionnaire for 7 days and performed the analysis for reliability and validity. We will do correlation analysis with the data with resting state functional MRI and tractography, brain connectivity, and plasma Aβ1-40 and Aβ1-42 amyloid protein.\n\nThe study aims to establish the data base of physical activity of patients with cognitive impairment in Taiwan. We will also analyze the efficacy of exercise with ICF model on physical function, physical activity and social engagements to provide an optimized design of exercise program for patients with cognitive impairment in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic,community sample', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Above 45 years old and had independent walking ability\n2. The MCI is diagnosed basically on Petersen's criteria (Petersen, 2001), CDR score of 0.5 but normal ADL/IADL, and not demented\n3. Diagnosis of Alzheimer's disease based on NINCDS-ADRDA criteria for probable AD (McKhann, et al., 1984)\n\nExclusion Criteria:\n\n* The subjects who had any neurological, musculoskeletal, cardio-pulmonary disorder which would cause gait disorder or cognitive dysfunction such as stroke, Parkinson disease, or arthritis were excluded"}, 'identificationModule': {'nctId': 'NCT01724151', 'briefTitle': 'Effects of Exercise Training in Patients With Mild Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Exercise Training in Patients With Mild Cognitive Impairment', 'orgStudyIdInfo': {'id': '200812152R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy adults', 'description': 'Healthy adults, over 45 years old'}, {'label': 'Mild cognitive impairment', 'description': 'subjects with mild cognitive impairment'}, {'label': "Alzheimer's disease", 'description': "subjects with Alzheimer's disease"}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming-Jang Chiu', 'role': 'STUDY_CHAIR', 'affiliation': 'Neurology department, National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}