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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-5yc53k |
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Date of registration:
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19/06/2012 |
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Primary sponsor: |
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Public title:
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Influence of strength training performed alone or associated with functional training on the cardiovascular system of elderly patients with Parkinson Disease.
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Scientific title:
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Effect of resistance training performed alone or associated with functional training on cardiovascular function and autonomic modulation in elderly patients with Parkinson Disease. |
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Date of first enrolment:
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27/02/2012 |
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Target sample size:
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60 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-5yc53k/ |
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Study type:
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Study design:
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Therapeutic, open, randomized, parallel, with 4 arms clinical trial.
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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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Claudia
Forjaz |
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Address:
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Av. Prof. Mello Moraes, 65 - Butantã
05508030
São Paulo
Brazil |
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Telephone:
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551130913136 |
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Email:
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cforjaz@usp.br |
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Affiliation:
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Escola de Educação Física e Esporte da Universidade de São Paulo |
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Name:
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Claudia
Forjaz |
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Address:
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Av. Prof. Mello Moraes, 65 - Butantã
05508030
São Paulo
Brazil |
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Telephone:
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551130913136 |
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Email:
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cforjaz@usp.br |
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Affiliation:
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Escola de Educação Física e Esporte da Universidade de São Paulo |
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Key inclusion & exclusion criteria
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Inclusion criteria: 45 Individuals with Parkinson's disease in stages from I to III assessed by the Hoehn and Yahr scale
15 Elderly subjects without Parkinson
Both genders
Aged above 60 years
Sedentary
Normotensive (systolic and diastolic blood pressure less than 140 and 90 mmHg, respectively)
No cardiovascular diseases or muscle-skeletal disorders
Not using medications that alter cardiovascular parameters, except in medications for treatment of Parkinson's disease
Exclusion criteria: Presence of complex arrhythmias and/or ischemia during exercise
Age minimum:
60Y
Age maximum:
0
Gender:
-
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Health Condition(s) or Problem(s) studied
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Parkinson Disease C10.228.140.079.862.500
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Intervention(s)
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Groups - Patients with Pakinson will be randomized to: control (n=15), resistance training (n=15)and resistance training associated with functional training(n=15). Subjects without Parkinson will participate in the Control intervention (n=15). Control: no training protocol. Resistance training: resistance exercise, 2 sessions / week, 7 exercises, 2-4 sets of 12 to 6 repetition maximum. Resistance training associated with Functional training: the same training with equipments that promote instability.
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Primary Outcome(s)
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Improvement of autonomic cardiovascular modulation assessed by spectral analysis of heart rate and blood pressure variabilities obtained at rest and in response to autonomic stimuli.
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Secondary Outcome(s)
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Improvement of cardiovacular function assessed by the measurement of blood pressure (auscultatory and ambulatory), cardiac output (CO2 rebreathing)and heart hate (ECG).
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Increase in maximal strength assessed by one repetition maximum test.
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Secondary ID(s)
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CEP-2011/42 CAAE-0041.0.342.000-11
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Source(s) of Monetary Support
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasília, DF, Brazil
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