Main
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Note: This record shows only 22 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:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-8sbbvp |
Date of registration:
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25/06/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efect of Resistance Exercise Volume on Body Composition, Physical Performance, Metabolic, Hormonal and Inflammatory Profile in Postmenopausal Pre Sarcopenic Women
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Scientific title:
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Sarcopenia: prevalence, disability and intervention in Postmenopausal women |
Date of first enrolment:
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01/05/2013 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-8sbbvp |
Study type:
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Intervention |
Study design:
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Safety experimental clinical study and efficacy, controlled randomized, parallel, open, with three arms.
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Phase:
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N/A
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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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Fábio Lera
Orsatti |
Address:
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Av Tutunas, 490
38061-500
Uberaba
Brazil |
Telephone:
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+ 55 (34) 3318 5067 |
Email:
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fabiorsatti@gmail.com |
Affiliation:
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Universidade Federal do Triângulo Mineiro |
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Name:
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Fábio Lera
Orsatti |
Address:
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Av Tutunas, 490
38061-500
Uberaba
Brazil |
Telephone:
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+ 55 (34) 3318 5067 |
Email:
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fabiorsatti@gmail.com |
Affiliation:
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Universidade Federal do Triângulo Mineiro |
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Key inclusion & exclusion criteria
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Inclusion criteria: 34 postmenopausal healthy women with the last period of menstruation more than a year and age more than 50 years; no hormone replacement therapy; no resistance exercise practitioners or similars; no vegetarians or tabagist; no gynecologic disease; diabetes or cardiac; no regular use medicine (aspirine or antibiotics) and no alcoholic.
Exclusion criteria: Women period previous of menopause and age less than 50 years; hormone replacement therapy users; resistance exercise practitioners or similars; vegetarians or tabagist; with gynecologic disease; diabetes or cardiac disease; regular use of medicine (aspirine or antibiotics) and alcoholic.
Age minimum:
50Y
Age maximum:
79Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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G08.686.157.500.625
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postmenopause
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Intervention(s)
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Groups with Intervention: Low Volume Exercise - n = 10 - (resistance exercise , load to 70% 1RM, eight exercises for the whole body, 3 sets for each exercise with 8 to 12 repetitions, rest interval between sets and exercises 60-90 seconds three times per week for 16 weeks) High Volume exercise - n = 12 - (resistance exercise , load to 70% 1RM, eight exercises for the whole body, 6 sets for each exercise with 8 to 12 repetitions, rest interval between sets and exercises 60-90 seconds three times per week for 16 weeks) group without intervention : Control - n = 12 (stretching exercises for the whole body, 2 times per week for 16 weeks) All participants underwent the following assessments: Nutritional Assessment: Daily food applied by an experienced professional (dietitian) containing the food intake of two days of the week and one day of the weekend. Food consumption was recognized and the quantification of energy and macronutrients (protein, fat and carbohydrates). The data were adjusted to body weight to decrease the interindividual differences. Anthropometric weight and height were performed on a platform scale with stadiometer coupled to calculate the body mass index. To investigate the distribution of abdominal fat was measured waist and hip circumference with a inextensible and inelastic tape with 0,5cm precision. To calculate the fat percentage, were assessed with skinfold caliper at four sites (biceps, triceps, subscapular and supra-iliac). Physical Evaluation: To calculate the training loads and maximum strength were performed the one-repetition maximum test (1-RM) in which was set to heat five to 10 repetitions with subjective load between 40-60% of 1-RM and 1 minute rest. Then the subjective load was increased to 60 to 80% required 1-RM and women carrying ou
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I02.233.543
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Other
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Primary Outcome(s)
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Expected Outcome (1): Top Improved hormonal blood profile, metabolic and inflammatory, according to laboratory methods (automated colorimetric, kinetic, and electrochemiluminescence immune enzyme assay) proposed by the manufacturers of each measurement kit comparing variations during the initial time and after 16 weeks deltas in percentage relative to low volume and control group.
Outcome Found (1): a better response to the metabolic and hormonal profile only for the low-volume group compared to the other was observed. Regarding the inflammatory profile the groups of low and high volume showed a higher attenuation compared to the control group after 16 weeks of resistance training.
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Secondary Outcome(s)
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Expected Outcome (1): Improves Superior body composition of the high-volume group as measured by the indirect method of skinfold caliper with and equations to estimate body density and fat percentage, comparing variations during the baseline and after 8 weeks deltas in percentage compared to the low volume and control group.
Outcome Found (1): There was no difference between groups for body fat reduction after 8 weeks of resistance training.
Expected Outcome (2): Top Increased physical performance muscle strength as measured by the test method of one repetition maximum, comparing variations during the baseline and after 8 weeks in percentage deltas relative to low volume and control group.
Outcome Found (2): There was an increase in the strength greater for the low-volume group compared to the high volume group and the control after 8 weeks of resistance training.
Expected Outcome (3): Top Increased physical performance of cardiorespiratory fitness as measured by the walk test method of a mile, comparing variations during the baseline and after 8 weeks in percentage deltas relative to low volume and control groups .
Outcome Found (3): an increase in cardiorespiratory fitness was observed only for high-volume group compared to the other groups after 8 weeks of resistance training.
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Source(s) of Monetary Support
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Fundação de Amparo à Pesquisa de Minas Gerais
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Fundação de Ensino e Pesquisa de Uberaba
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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