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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-5yc53k
Date of registration: 19/06/2012
Primary sponsor: Escola de Educação Física e Esporte da Universidade de São Paulo - Brazil
Public title: Influence of strength training performed alone or associated with functional training on the cardiovascular system of elderly patients with Parkinson Disease.
Scientific title: Effect of resistance training performed alone or associated with functional training on cardiovascular function and autonomic modulation in elderly patients with Parkinson Disease.
Date of first enrolment: 27/02/2012
Target sample size: 60
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-5yc53k/
Study type: 
Study design:  Therapeutic, open, randomized, parallel, with 4 arms clinical trial.  
Countries of recruitment
Brazil
Contacts
Name: Claudia  Forjaz
Address:  Av. Prof. Mello Moraes, 65 - Butantã 05508030 São Paulo Brazil
Telephone: 551130913136
Email: cforjaz@usp.br
Affiliation:  Escola de Educação Física e Esporte da Universidade de São Paulo
Name: Claudia  Forjaz
Address:  Av. Prof. Mello Moraes, 65 - Butantã 05508030 São Paulo Brazil
Telephone: 551130913136
Email: cforjaz@usp.br
Affiliation:  Escola de Educação Física e Esporte da Universidade de São Paulo
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Parkinson Disease
C10.228.140.079.862.500
Intervention(s)
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.
Primary Outcome(s)
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.
Secondary Outcome(s)
Improvement of cardiovacular function assessed by the measurement of blood pressure (auscultatory and ambulatory), cardiac output (CO2 rebreathing)and heart hate (ECG).
Increase in maximal strength assessed by one repetition maximum test.
Secondary ID(s)
CEP-2011/42 CAAE-0041.0.342.000-11
Source(s) of Monetary Support
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasília, DF, Brazil
Secondary Sponsor(s)
Associação Brasil Parkinson - São Paulo, SP, Brazil
Centro de Estudos em Psicobiologia e Exercício da Universidade Federal de São Paulo - São Paulo, SP, Brazil
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