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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-4qzm6s
Date of registration: 04/03/2012
Primary sponsor: São Paulo State University - Brazil
Public title: Physical Exercises, neuropsychiatric disturbances and Activity Daily Living performance on women with Alzheimer´s Disease.
Scientific title: A controlled clinical trial on the effects of physical exercise on neuropsychiatric disorders and instrumental activities in women with Alzheimer’s disease
Date of first enrolment: 01/03/2010
Target sample size: 20
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-4qzm6s/
Study type: 
Study design:  Controlled Clinical Trial, Open Label, Paralel, non-randomized, two arm study. single-blinded  
Countries of recruitment
Brazil
Contacts
Name: Carla  Crispim Nascimento
Address:  Avenida 24-A, 1515 13506900 Rio Claro Brazil
Telephone: 19-35264312
Email: carla_unesp@yahoo.com.br
Affiliation:  Carla M. C. Nascimento
Name: Carla  Crispim Nascimento
Address:  Avenida 24-A, 1515 13506900 Rio Claro Brazil
Telephone: 19-35264312
Email: carla_unesp@yahoo.com.br
Affiliation:  Carla M. C. Nascimento
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Aging, Alzheimer´s Disease, Physical Exercise
G07.700.320.124
C10.228.140.380.100
F01.145.632
F04.096.544.504
Intervention(s)
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.
Primary Outcome(s)
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
Instrumental Day-living activities were evaluated by the Pfeffer Instrumental Activities Questionnaire
Secondary Outcome(s)
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.
Secondary ID(s)
Protocolo #5024
Source(s) of Monetary Support
Fundação para o Desenvolvimento da Uneps - FUNDUNESP - São Paulo, SP, Brazil
Fundo Nacional de Saúde - Ministério da Saúde/ FNS-MS - Brasília, DF, Brazil
Secondary Sponsor(s)
Departamento de Educação Física - Instituto de Biociencias da UNESP/RC - Rio Claro, SP, Brazil
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