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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-9v9cwf |
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Date of registration:
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09/01/2012 |
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Primary sponsor: |
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Public title:
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Interaction between genes of inflammatory mediators and the effects of physical exercise in older women
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Scientific title:
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Interaction between single nucleotide polymorphisms of the genes of TNF-alpha, IL6, IL10 and brain-derived neurotrophic factor (BDNF) and the effects of physical exercise in older women |
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Date of first enrolment:
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03/11/2011 |
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Target sample size:
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260 |
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Recruitment status: |
recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-9v9cwf/ |
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Study type:
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Study design:
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Randomized clinical trial, 2-arm, prospective, open and parallel.
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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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Leani
Pereira |
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Address:
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Av. Antônio Carlos, 6627 - Pampulha
31270-901
31270-901
Brazil |
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Telephone:
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31-3409-7410 |
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Email:
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leanismp.bh@terra.com.br |
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Affiliation:
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Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG |
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Name:
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Leani
Pereira |
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Address:
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Av. Antônio Carlos, 6627 - Pampulha
31270-901
31270-901
Brazil |
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Telephone:
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31-3409-7410 |
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Email:
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leanismp.bh@terra.com.br |
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Affiliation:
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Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women above the age of 65; community-dwelling
Exclusion criteria: Elderly people with cognitive impairment detectable by the Mini Mental State Examination, acute phase inflammatory disease, tumor growth in the last five years, current use of immunomodulating medications, amputation or lower limb fracture in the last 6 months, presence of any neurological disease and current participation in an alternative exercise programme.
Age minimum:
65Y
Age maximum:
99Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Aging,inflammation, exercise, sarcopenia G07.700.320.124 C10.597.613.612.500 C23.550.470 D12.644.276.374 G05.365.795.598
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Intervention(s)
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Two training protocols: Group 1: muscle strength training of the lower limbs at 75% of 1 maximal resistance, 3 times per week for 10 weeks. Group 2: aerobic training of 5 minutes warm up, 40 minutes of aerobic activity (intensity of 65% to 80% of maximum heart rate) and 5 minutes of cool down, three times per week for 10 weeks.
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Primary Outcome(s)
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Functional capacity: timed up and go, Sit-to-stand test, 10-Meter Wlak Test
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Plasma levels: interleukin-6 (IL-6), interleukin-10 (IL-10), soluble tumor necrosis factor alpha receptor-1 (sTNFR1), soluble tumor necrosis factor alpha receptor-2 (sTNFR2), Brain-Derived Neurotrophic Factor (BDNF) measured by ELISA method.
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Single nucleotide polymorphism (SNP): TNF-alpha (rs1800629); IL6 (rs1800795), IL10 (rs1800896), BDNF (rs6265 and rs4923463)
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Secondary Outcome(s)
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Aerobic capacity: Six-Minute Walk Test (distance); Shuttle Walking Test (distance).
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Allostatic load: by waist-hip ratio,salivary cortisol concentrations, Perceived Stress Scale, plasma levels of IL-6 and soluble tumor necrosis factor alpha receptor-1 (sTNFR1).
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Depressive symptoms: Geriatric depression scale
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Muscle strength: strength of the muscles in the knee joint measured by Biodex System 3 Pro ® isokinetic dynamometer (Biodex Medical Systems Inc., Shirley, NY, USA); hand grip, by JAMAR dynamometer (PC5030JI)
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Secondary ID(s)
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0038.0.203.000-10
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) - Brazil
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Fundação de Amparo à Pesquisa do Estado de Minas Gerais - Fapemig - Brazil
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