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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-4qzm6s |
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Date of registration:
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04/03/2012 |
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Primary sponsor: |
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Public title:
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Physical Exercises, neuropsychiatric disturbances and Activity Daily Living performance on women with Alzheimer´s Disease.
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Scientific title:
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A controlled clinical trial on the effects of physical exercise on neuropsychiatric disorders and instrumental activities in women with Alzheimer’s disease |
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Date of first enrolment:
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01/03/2010 |
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Target sample size:
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20 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-4qzm6s/ |
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Study type:
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Study design:
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Controlled Clinical Trial, Open Label, Paralel, non-randomized, two arm study. single-blinded
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Carla
Crispim Nascimento |
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Address:
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Avenida 24-A, 1515
13506900
Rio Claro
Brazil |
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Telephone:
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19-35264312 |
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Email:
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carla_unesp@yahoo.com.br |
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Affiliation:
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Carla M. C. Nascimento |
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Name:
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Carla
Crispim Nascimento |
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Address:
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Avenida 24-A, 1515
13506900
Rio Claro
Brazil |
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Telephone:
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19-35264312 |
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Email:
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carla_unesp@yahoo.com.br |
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Affiliation:
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Carla M. C. Nascimento |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women over 60 years with clinical diagnosis of probable Alzheimer's disease in mild to moderate stages of the disease, residents in the community with independent locomotion.
Exclusion criteria: Elderly males, elderly without cognitive impairment, with other neurological conditions, limited mobility to preclude the exercise protocol and physical prior participation in other exercise programs.
Age minimum:
60Y
Age maximum:
99Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Aging, Alzheimer´s Disease, Physical Exercise G07.700.320.124 C10.228.140.380.100 F01.145.632 F04.096.544.504
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Intervention(s)
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The intervention protocol was basically aerobics (moderate intensity over long duration) and it was composed by different types of activities that simultaneously benefited other components of functional capacity, such as flexibility (stretching), muscular resistance (specific exercises for large muscle groups and with series over 15/20 repetitions according to the volume overload), motor coordination (i.e. rhythmic activities, sequences to be completed) and balance (i.e. games and recreational motor activities with priority on changes on the gravidity center and on direction, unipodal support exercises and unexpected perturbances on systems involved on balance). The intensity previwed for the protocol was between 60 and 80% of the Maximal Heart Rate (according the age and monitored). All participants recruited were invited to participate of this research, however only 10 of them accepted to eralize the sessions of physical exercises during the 24 weeks (six months), with 3 sessions per week, and 60 minutes of duration always at the afternoon period (since 5 to 6 p.m.). The other elderlies invited to the study that did not realized the referred protocol did composed the control group and did not realized any kind of physical exercises on the period of the research.
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Primary Outcome(s)
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Cognitive Functions were evaluated by Mini-Mental State Examination and the Neuropsychiatric Disturbances were measured by Neuropsychiatric Inventory (NPI) to verify specific domains as: hallucinations, delusions, agitation, depressive symptoms, anxiety, euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, nighttime disturbances and appetite/eating changes
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Instrumental Day-living activities were evaluated by the Pfeffer Instrumental Activities Questionnaire
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Secondary Outcome(s)
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It was expected the attenuation of neuropsychiatric disorders and a possible improvement in the performance of instrumental activities of daily life by improving mobility and functional components of these participants in relation to the control group
The functional capacity was not included in this study but data were collected to monitor this parameter through the Battery Test Engines AAHPERD adapted for the elderly.
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Secondary ID(s)
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Protocolo #5024
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Source(s) of Monetary Support
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Fundação para o Desenvolvimento da Uneps - FUNDUNESP - São Paulo, SP, Brazil
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Fundo Nacional de Saúde - Ministério da Saúde/ FNS-MS - Brasília, DF, Brazil
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