Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-29 @ 4:19 PM
Study NCT ID:
NCT01183806
Status:
COMPLETED
Last Update Posted:
2012-03-20
First Post:
2010-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068836', 'term': 'Rivastigmine'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-17', 'lastUpdatePostDateStruct': {'date': '2012-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Patients' Quality of life", 'timeFrame': 'Monthly for six months', 'description': "Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version"}], 'secondaryOutcomes': [{'measure': 'Cognition', 'timeFrame': 'Monthly for six months', 'description': 'Cognition change, through Mini-Mental State examination (MMSE)'}, {'measure': "Caregivers' Quality of life", 'timeFrame': 'Monthly for six months', 'description': "Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version"}, {'measure': 'Activities of daily living', 'timeFrame': 'Monthly for six months', 'description': 'Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version'}, {'measure': 'Functional mobility', 'timeFrame': 'Monthly for six months', 'description': 'Functional mobility, through Time Up and Go test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Exercise', 'Rivastigmine', 'Quality of life'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '24938502', 'type': 'DERIVED', 'citation': "Aguiar P, Monteiro L, Feres A, Gomes I, Melo A. Rivastigmine transdermal patch and physical exercises for Alzheimer's disease: a randomized clinical trial. Curr Alzheimer Res. 2014;11(6):532-7. doi: 10.2174/1567205011666140618102224."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether a exercise program when combined with rivastigmine (Exelon patch) drug treatment compared with rivastigmine drug treatment alone would improve quality of life, ability to perform activities of daily living (ADL) and cognition in patients with Alzheimer's disease.\n\nHypothesis:\n\nHo: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients.\n\nH1: Rivastigmine drug treatment combined with exercise is superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients, with an expectative of 15% of improvement in the quality of life scale measurement", 'detailedDescription': "After screening and informed consent, that will be collected demographical data from patient. Another researcher will evaluate the cognition, through MMSE; the activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease; patient and caregiver's quality of life through Quality of life scale in Alzheimer's disease (QOL-AD); functional mobility, through Time Up and Go test.\n\nAfterwards, the pharmacist will give the medicine, orientations about its administration and clarify possible doubts. Therapy will begin with the small patch of 5 mg/24 h and, if well tolerated, the dose will be increased to the 10 mg/24 h patch.\n\nThe patients will be randomly assigned, through a computer program list, to exercise or control group. The patient and caregiver exercise group will receive information about the two-day/week exercise program at physiotherapy ambulatory. Monthly, all patients and caregiver will be clinically reevaluated during six months.\n\nThe forty minutes exercise program will include aerobic, strength, flexibility and balance training, organize in the follow sequence:\n\n\\- Ten minutes of global stretching (shoulder girdle, upper limbs, lower limbs and trunk) along the beginning and final of the session. Each stretch posture will last 30 seconds.\n\nAlternation of A and B sessions, lasting 30 minutes:\n\n* Session A: Aerobic training on treadmill. Progression of 10 to 30 minutes of continuous aerobic activity\n* Session B: - Resisted kinesiotherapy (strength training) with use of weights to be attached around the ankles and wrist of initially 1 Ib. The physiotherapist will evaluate if patient can progress to a higher weight during sessions.\n* Walking over obstacles on the ground and direction change with use of cones.\n* Functional activities like transfer exercise (stand/sit exercise) and squatting The monitoring of the exercise, its progress and any other observation will be register in a control form by the physiotherapist."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previous diagnosis of probable Alzheimer's disease\n* At least 55 years of age\n* Same caregiver (familiar or paid one) for at least 3 months before, who is able to follow the patient in a two-day/week exercise program\n* Do not be taking other prescribed medication for Alzheimer disease\n* Treated stable hypertension\n\nExclusion Criteria:\n\n* Mini-Mental State Examination (MMSE) score of less than 12\n* Can't follow simple commands;\n* Can't answer two or more items of Quality of life questionnaire\n* Practiced regular exercise or physiotherapy/ occupational therapy in the last two months.\n* Diagnosed psychiatric condition (including depression).\n* Use of neuroleptic drugs\n* Orthopedic, neurologic, or behavioral limitations that may preclude exercise training\n* Visual or hearing impairment that may preclude exercise training or comprehension"}, 'identificationModule': {'nctId': 'NCT01183806', 'briefTitle': "Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients", 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Bahia'}, 'officialTitle': "Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients", 'orgStudyIdInfo': {'id': 'PA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivastigmine and exercise program', 'description': 'Experimental group: Rivastigmine and exercise program: All patients will monthly receive Rivastigmine (Exelon patch). The exercise training program consists of two 40-minute sessions per week for six months and includes aerobic, strength, flexibility and balance training', 'interventionNames': ['Drug: Rivastigmine', 'Other: Exercise training program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rivastigmine', 'description': 'Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch)', 'interventionNames': ['Drug: Rivastigmine']}], 'interventions': [{'name': 'Rivastigmine', 'type': 'DRUG', 'otherNames': ['Rivastigmine use'], 'description': 'All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased', 'armGroupLabels': ['Rivastigmine', 'Rivastigmine and exercise program']}, {'name': 'Exercise training program', 'type': 'OTHER', 'otherNames': ['Rivastigmine use and exercise program'], 'description': 'Exercise training program', 'armGroupLabels': ['Rivastigmine and exercise program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40.110-170', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Ferderal University of Bahia - DINEP', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'zip': '40110170', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Federal University of Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Paula Aguiar', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal University of Bahia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Bahia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ailton de Souza Melo,PhD', 'investigatorFullName': 'Ailton de Souza Melo', 'investigatorAffiliation': 'Federal University of Bahia'}}}}