Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 4:48 AM
Study NCT ID:
NCT00446394
Status:
COMPLETED
Last Update Posted:
2012-10-19
First Post:
2007-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006295', 'term': 'Health Resources'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-18', 'studyFirstSubmitDate': '2007-03-08', 'studyFirstSubmitQcDate': '2007-03-08', 'lastUpdatePostDateStruct': {'date': '2012-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in cognitive status', 'timeFrame': 'baseline, 3, 6, 12, 18, 24, 30, and 36 months'}], 'secondaryOutcomes': [{'measure': 'Changes in health, affective, and functional status', 'timeFrame': 'baseline, 3, 6, 12, 18, 24, 30, and 36 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cognition disorder', 'functional ability', 'psychomotor function', 'psychopathology', 'quality of life'], 'conditions': ['Mild Cognitive Impairment', 'Dementia']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to evaluate an exercise and health promotion program for older adults with mild memory loss. The study will investigate the efficacy of a memory-enhanced exercise and health promotion program to determine whether it is more effective than a social walking program in delaying further memory decline, improving mood and physical function, and enhancing quality of life.', 'detailedDescription': "This project is a randomized controlled trial to evaluate the efficacy of a group exercise and health promotion program designed specifically for older adults with Mild Cognitive Impairment (MCI). This study builds upon previous studies designed for cognitively intact older adults, with a supplemental study using a modified intervention for MCI participants, and for individuals with Alzheimer's disease.\n\nTaken together, these prior investigations support the efficacy of behaviorally based exercise interventions in improving cognitive, physical, and affective status in cognitively intact and demented older adults. Results from a feasibility study suggest that these positive outcomes can also be obtained in older adults with MCI.\n\nThe current study will investigate the efficacy of the modified exercise program called RALLI (Resources and Activities for Life Long Independence) to determine whether it is more effective than the control condition, a social walking program (SW), in delaying cognitive decline, improving self-rated health and health behaviors, improving affect and physical function, and enhancing quality of life. The long-term efficacy of RALLI to delay conversion of MCI to dementia, reduce physical disability, maintain independent living, and improve physiological health indicators will also be investigated.\n\nOne hundred seventy participants over the age of 70 who meet American Academy of Neurology criteria for MCI will be recruited from independent living retirement residences. Participants will be randomly assigned to one of the two conditions (RALLI and SW) and assessed at baseline, post treatment (3 months), and follow up visits every 6 months for a total of 3 years (months 6, 12, 18, 24, 30, and 36). The hypothesis is that RALLI participants will experience better post-treatment outcomes than SW participants, and that gains will be maintained over 36 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild Cognitive Impairment defined as\n* \\- Memory complaint\n* \\- Objective memory impairment for age and education\n* \\- Largely intact general cognitive function\n* \\- Essentially preserved activities of daily living\n* \\- Not already diagnosed with dementia\n* Insufficient physical activity defined as less than 150 minutes per week of moderate intensity physical activity\n* Not currently in an exercise program similar to the study program\n\nExclusion Criteria:\n\n* Not ambulatory\n* Expected to move from the study geographic area during the study period\n* Have a known terminal illness\n* Actively suicidal, hallucinating, or delusional\n* Hospitalized for a psychiatric disorder in the 12 months before baseline\n* Uncontrolled chronic conditions, e.g. uncontrolled hypertension, unstable angina, uncontrolled blood glucose\n* Blind or deaf'}, 'identificationModule': {'nctId': 'NCT00446394', 'briefTitle': 'Exercise and Activities for Independent Living With Mild Cognitive Impairment (MCI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Exercise & Health Promotion for MCI: A Controlled Trial', 'orgStudyIdInfo': {'id': '30692-J'}, 'secondaryIdInfos': [{'id': '2R01AG014777', 'link': 'https://reporter.nih.gov/quickSearch/2R01AG014777', 'type': 'NIH'}, {'id': 'IA0100', 'type': 'OTHER', 'domain': 'UW'}, {'id': '06-3067-C', 'type': 'OTHER', 'domain': 'UW HSD old IRB application #'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Behavioral: Resources and Activities for Life Long Independence (RALLI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Behavioral: Social Walking program (SW)']}], 'interventions': [{'name': 'Resources and Activities for Life Long Independence (RALLI)', 'type': 'BEHAVIORAL', 'description': 'Strengthening exercises, encouragement to walk daily, pedometer reading, health promotion information for 1.5 hours weekly for 9 weeks', 'armGroupLabels': ['1']}, {'name': 'Social Walking program (SW)', 'type': 'BEHAVIORAL', 'description': 'Group support for walking, pedometer reading, 1 hour weekly for 9 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Research Group on Aging, Department of Psychosocial and Community Health, University of Washington School of Nursing', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Linda Teri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Linda Teri', 'investigatorAffiliation': 'University of Washington'}}}}