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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-3q3q98
Date of registration: 22/02/2013
Primary sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho - Rio Claro, SP, Brazil
Public title: Weight Training, Apathy and Motor Function in Alzheimer's Disease
Scientific title: Weight Training, Apathy Syndrome and Motor Function in Patients With Alzheimer's Disease
Date of first enrolment: 15/03/2011
Target sample size: 28
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-3q3q98/
Study type: 
Study design:  Clinical trial, controlled, nonrandomized, two arms, parallel, single blinded trial, prognostic focus  
Countries of recruitment
Brazil
Contacts
Name: Salma Stéphany  Hernandez
Address:  Av. 24A, 1515 13506--900 Rio Claro Brazil
Telephone: +55(19)3526-4100
Email: salma_soleman@yahoo.com.br
Affiliation:  Universidade Estadual Paulista Júlio de Mesquita Filho
Name: Vagner  Morae
Address:  Av. 24A, 1515 13506-900 Rio Claro Brazil
Telephone: +55(19)3526-4107
Email: scaib@rc.unesp.br
Affiliation:  Universidade Estadual Paulista Júlio de Mesquita Filho
Key inclusion & exclusion criteria
Inclusion criteria: Patients diagnosed with Alzheimer´s disease both genders aged 60 years and over. Elderly people with mild and moderate levels of dementia. Patients and their caregivers that were consistent with the procedures of the study and who signed the Instrument of Consent. Patients ambulating
Exclusion criteria: Patients with other neuropsychiatric conditions or clinical comorbidities that interfere with the apathetic condition, provided in front or cognitive motor procedures to be developed. Patients who had contraindications to physical activity. Patients with bone-mioarticulares problems, serious heart disease or amputations


Age minimum: 60Y
Age maximum: 0
Gender: -
Health Condition(s) or Problem(s) studied
Alzheimer´s disease, Apathy, Reduced motor function
C10.228.140.380.100
F03.550.650
F01.470.137
F00-F99
Intervention(s)
The training group consisted of 14 patients will perform weight training for four months, on nonconsecutive days, 60 minutes each session. Will be performed three sets of 20 repetitions for the major muscle groups: Chest, Large Dorsal, quadriceps femoral, biceps and triceps curl. Will be adopted a two-minute rest between sets and exercises. The social interaction group consisted of 14 patients have same duration and frequency as the training group, however, non systematized activities are performed. The purpose of this group is to promote greater social interaction among patients, without the practice of systematized physical activity. May be conducted activities of reading, poetry, music and painting.Groups will be allocated for convenience, trying pair age to education and disease duration. The assessment followed by a "blind" evaluator regarding the selection groups that were trained to minimize possible errors during evaluations of patients
Primary Outcome(s)
Apathy Syndrome - Lowering scores measured using the Neuropsychiatric Inventory (apathy domain) after 4 months of weight training and after 4 months of social interaction in relation to the time prior to this practices
Conclusions - After 4 months of weight training there was a significant increase in the number of repetitions performed for elbow flexion test used to measure the strength of the upper limb ( American Alliance for Health Physical Education Recreation and Dance battery tests). There was also a significant increase in the distance, in centimeters, obtained by the Bank of Wells used to measure flexibility in weight training group. For other outcomes were not found significant results after weight training, such as results were not found for outcomes related to practice social interaction
Frontal cognitive functions - Increasing scores measured by the Mini Mental State Examination; Montreal Cognitive Assessment (consists in a scale with nine subtests that assess specific cognitive functions such as abstraction, naming, calculation and others), clock drawing test and frontal assessment battery. Furthermore, increasing the number of words spoken obtained by verbal fluency test after 4 months of weight training and after 4 months of social interaction in relation to the time prior to this practices
Motor function - After 4 months of weight training and after 4 months of social interaction: Decrease time spent, in seconds, to perform the tests walk 800 meters, to sit and get up from the chair and moving around the house, climbing stairs, getting up from the ground; manuals abilities and put on socks (assessed by Andreotti & Okuma Battery). Moreover, increase in centimeters, the distance reached by the of Wells protocol used to measure flexibility, increase the number of repetitions performed for elbow flexion used to measure the strength of the upper limb (taken from the American Alliance for Health Physical Education Recreation and Dance battery) and increase the number of repetitions performed to sit and get up from the chair used to measure the strength of the lower limbs (removed battery testing Rikli & Jones). Compared to aterior practice of weight training and social interaction
Secondary Outcome(s)
Conclusions - After 4 months of weight training and after 4 months of social interaction patients with Alzheimer's dementia not exceed 7 points on the Cornell Scale for Depression in Dementia
Depressive symptoms - no more than 7 points score on the Cornell Scale for Depression in Dementia after 4 months of weight training and after 4 month of social interaction
Secondary ID(s)
protocolo nº 4826
Source(s) of Monetary Support
Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasília, SP, Brazil
Secondary Sponsor(s)
Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasília, SP, Brazil
Universidade Estadual Paulista Júlio de Mesquita Filho - Rio Claro, SP, Brazil
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