Rivastigmine
DrugAll patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased
Other names: Rivastigmine use
NCT Number: NCT01183806
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.
Hypothesis:
Ho: Rivastigmine drug treatment combined with exercise is not superior to rivastigmine drug treatment to improve quality of life of Alzheimer's disease patients.
H1: 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
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Notify Me55 year and older
All sexes
Interventional
Phase 3
Federal University of Bahia, Salvador, Estado de Bahia, Brazil
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.
Afterwards, 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.
The 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.
The forty minutes exercise program will include aerobic, strength, flexibility and balance training, organize in the follow sequence:
Alternation of A and B sessions, lasting 30 minutes:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased
Other names: Rivastigmine use
Exercise training program
Other names: Rivastigmine use and exercise program
Time frame: Monthly for six months
Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Time frame: Monthly for six months
Cognition change, through Mini-Mental State examination (MMSE)
Time frame: Monthly for six months
Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version
Time frame: Monthly for six months
Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version
Time frame: Monthly for six months
Functional mobility, through Time Up and Go test
Federal University of Bahia
Other
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