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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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27 May 2013 |
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Main ID: |
RBR-2g27zn |
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Date of registration:
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04/01/2012 |
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Primary sponsor: |
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Public title:
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Effect of the physical training in community-dwelling older women: randomized clinical assay
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Scientific title:
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Effectiveness of the training with isolated load, training with load associated with the aerobic and isolated aerobic training on the functional and muscular performance, on the plasmáticas concentrations of inflammatory mediators and on the satisfaction with the life in community-dwelling older women |
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Date of first enrolment:
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01/08/2011 |
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Target sample size:
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48 |
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Recruitment status: |
not yet recruiting |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-2g27zn/ |
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Study type:
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Intervention |
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Study design:
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Clinical trail, controled, not randomized, with three groups of intervention
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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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Lygia
Lustosa |
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Address:
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Av. Mário Wernwck 1685 - Buritis
30455610
Belo Horizonte
Brazil |
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Telephone:
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99831854 |
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Email:
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lygia.paccini@gmail.com |
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Affiliation:
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Centro Universitário de Belo Horizonte - Uni-BH |
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Name:
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Lygia
Lustosa |
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Address:
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Av. Mário Wernwck 1685 - Buritis
30455610
Belo Horizonte
Brazil |
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Telephone:
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99831854 |
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Email:
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lygia.paccini@gmail.com |
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Affiliation:
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Centro Universitário de Belo Horizonte - Uni-BH |
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Key inclusion & exclusion criteria
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Inclusion criteria: Aging, community-dwelderly women, without distinction of race and/or social class, with equal age or above of 65 years old.
Exclusion criteria: Previously submitted the orthopeadic surgeries of the inferiors members and/or with history of fracture it less has of one year; those that will not be capable to walking without aid; carrying of neurological illnesses; that to present some type of inflammatory illness in the acute phase that they can intervene with the tests; neoplasia in the five previous years; that to use drugs with ample action on the immunological system; that to present detectable cognitivas alterations by means of Mini-Examination of the Mental State; that to carry through physical activity of regular form for more than two times in the week; to make use of some type of canal choke of calciun (Ca++), inhibitors of the Converting Converting Enzyme of Angiotensina II (ECA) and use of estatinas.
Age minimum:
65Y
Age maximum:
90Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Sarcopenia, musculoskeletal disfunction, functional capacity C10.597.613.612.500 G07.700.320.124
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Intervention(s)
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The group of isolated load training (GFM) will go to carry through exercises with load for inferior members, by means of the rank of load adjusted for each participant. The program will be composed of exercises eccentric and concentric, for the extensores and flexores of knee, guided and folloied for one of the researchers. The used load will be the correspondent 75% of 1 RM, calculated to each participant. The exercises will be carried through during 10 weeks or 30 consecutive sessions, 3 times/week. Each exercise will be carried through with 8 repetitions and 3 series, interval of recovery of 30 seconds between each series and one minute between each exercise. The group load training associated with the aerobic exercise (GAFM) will carry through the same exercises for inferior members, resisted, with load adjusted for each volunteer, as described for the group GFM, associates to trainings aerobic previous. The aerobico training will be carried through at the beginning of the session, by means of walked, in mat, during 30 minutes, with moderate intensity (65-75% of the foreseen maximum FC for the age - FCmax). The aged ones will be monitored by researchers that will guarantee the reach of the intensity during all period of aerobic training. The third group will be the group of isolated aerobic training(GA) that it will go to carry through a aerobic training, by means of walked, in mat, during 30 minutes, with moderate intensity (65-75% of the FCmax). The aged ones will be monitored by researchers that will guarantee the reach of the intensity during all period of aerobic training. After the period of intervention, all the volunteers will be reevaluated in the same way that previously to the intervention.
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Primary Outcome(s)
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Functional performance evaluated by the Timed up and go test (TUG), walked speed test of 10m (TC10), test of seat-stand and shuttle walking test (SWT).The TUG consists of the accomplishment of the task of raising of a chair standard of 45 cm of height, to walk for three meters, to turn, to come back and to seat in the same chair. The time expended for the accomplishment of all the passage was used for analysis. The test seat-stand consists of the task of seat-stand of a chair, five consecutive times, with the crossed arms the front of the trunk. The time expended for the accomplishment of the complete task is used for analysis. In the TC10, the volunteer was guided to walk, in its normal passed one, for a plain passage of 14 meters. The two initial meters for acceleration and two ends for the deceleration had been disrespected. The displacement time, in seconds, by the 10 meters, was written down and used for analysis. The SWT is composed for 12 periods of training, being the speed of the first period of training of 0,5 meters for second and to each period of training the speed increases 0,17 meters for second. Before initiating the test, the arterial pressure (Pará) and the cardiac frequency (FC) they had been mensuradas. The volunteer was instructed to walk in a running plan, with ten meters of gone and ten meters in return. The volunteer initially, after to hear a sonorous signal, initiated the walked one until the end of the passage. Each new period of training was initiated with a sound with different characteristic, indicating the necessity to increase the speed of the walked one. When the volunteer reached the end of the passage before the signal, it was guided to wait the drive of the following signal marching in the place. In case that the participant had not reached the end of the passage for two consecutive times, the test was interrupted. In the distance total covered in the test it was calculated and used as given of the performance in the test, disrespecting the last return not completed.
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Secondary Outcome(s)
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Plasmatics indices of inflammatory mediators (Il-6 and TNF) mensuread high-sensibility lits by ELISA; muscular force of the inferior members esteem by the seat-stand test; force of manual hold evaluated by the Jamar dynamometer; clinical and antropometrical measures (circumference of waist, index of corporal mass, ponderal weight); satisfaction with the life (two questions of the Center of Epidemiological Studies Depression Scale - CES-D); cognitives aspects for Addenbrooke’s Cognitive Examination - Revised(ACE-R) and Depression geriatrics scale; urinary and fecal incontinence for the fecal constipation (fecal contipation system)and micicional frequencie;
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Secondary ID(s)
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048/2009
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WHO/ICTRP
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Source(s) of Monetary Support
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Centro Universitário de Belo Horizonte - Uni-BH - Brazil
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