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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
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:
- 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.
Alternation of A and B sessions, lasting 30 minutes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine and exercise program | Experimental | 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 |
|
| Rivastigmine | Active Comparator | Control group : Rivastigmine All patients will monthly receive Rivastigmine (Exelon patch) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivastigmine | Drug | All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patients' Quality of life | Patients' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version | Monthly for six months |
| Measure | Description | Time Frame |
|---|---|---|
| Cognition | Cognition change, through Mini-Mental State examination (MMSE) | Monthly for six months |
| Caregivers' Quality of life | Caregivers' Quality of life of assessed by Quality of life scale in Alzheimer's disease (QOL-AD)- Portuguese version |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Aguiar | Federal University of Bahia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ferderal University of Bahia - DINEP | Salvador | Estado de Bahia | 40.110-170 | Brazil | ||
| Federal University of Bahia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24938502 | Derived | 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. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068836 | Rivastigmine |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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|
| Exercise training program | Other | Exercise training program |
|
|
| Monthly for six months |
| Activities of daily living | Activities of daily living, through Activities of Daily Living Questionnaire of Alzheimer disease - portuguese version | Monthly for six months |
| Functional mobility | Functional mobility, through Time Up and Go test | Monthly for six months |
| Salvador |
| Estado de Bahia |
| 40110170 |
| Brazil |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |