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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-9v9cwf
Date of registration: 09/01/2012
Primary sponsor: Universidade Federal de Minas Gerais - Brazil
Public title: Interaction between genes of inflammatory mediators and the effects of physical exercise in older women
Scientific title: 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
Date of first enrolment: 03/11/2011
Target sample size: 260
Recruitment status: recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-9v9cwf/
Study type: 
Study design:  Randomized clinical trial, 2-arm, prospective, open and parallel.  
Countries of recruitment
Brazil
Contacts
Name: Leani  Pereira
Address:  Av. Antônio Carlos, 6627 - Pampulha 31270-901 31270-901 Brazil
Telephone: 31-3409-7410
Email: leanismp.bh@terra.com.br
Affiliation:  Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG
Name: Leani  Pereira
Address:  Av. Antônio Carlos, 6627 - Pampulha 31270-901 31270-901 Brazil
Telephone: 31-3409-7410
Email: leanismp.bh@terra.com.br
Affiliation:  Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Aging,inflammation, exercise, sarcopenia
G07.700.320.124
C10.597.613.612.500
C23.550.470
D12.644.276.374
G05.365.795.598
Intervention(s)
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.
Primary Outcome(s)
Functional capacity: timed up and go, Sit-to-stand test, 10-Meter Wlak Test
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.
Single nucleotide polymorphism (SNP): TNF-alpha (rs1800629); IL6 (rs1800795), IL10 (rs1800896), BDNF (rs6265 and rs4923463)
Secondary Outcome(s)
Aerobic capacity: Six-Minute Walk Test (distance); Shuttle Walking Test (distance).
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).
Depressive symptoms: Geriatric depression scale
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)
Secondary ID(s)
0038.0.203.000-10
Source(s) of Monetary Support
Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) - Brazil
Fundação de Amparo à Pesquisa do Estado de Minas Gerais - Fapemig - Brazil
Secondary Sponsor(s)
Escola de Educação Física, Fisioterapia e Terapia Ocupacional - UFMG - Brazil
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