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-7p23c3 |
Date of registration:
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10/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effects of Strength Training on women with Polycystic Ovary Syndrome
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Scientific title:
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Effect of resistance physical training periodization on women with Hyperandrogenic Anovulation
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Date of first enrolment:
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01/02/2010 |
Target sample size:
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Recruitment status: |
Recruitment completed |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-7p23c3 |
Study type:
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Intervention |
Study design:
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This is a therapeutic, open, single-arm.
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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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Rosana Maria
dos Reis |
Address:
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Avenida Bandeirante 3900
14049-900
Ribeirão Preto
Brazil |
Telephone:
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+55(16)3602 2926 |
Email:
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romareis@fmrp.usp.br |
Affiliation:
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Faculdade de Medicina de Ribeirão Preto |
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Name:
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Rosana Maria
dos Reis |
Address:
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Avenida Bandeirante 3900
14049-900
Ribeirão Preto
Brazil |
Telephone:
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+55(16)3602 2926 |
Email:
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romareis@fmrp.usp.br |
Affiliation:
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Faculdade de Medicina de Ribeirão Preto |
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Key inclusion & exclusion criteria
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Inclusion criteria: Age between 18 to 37 years;
Body Mass Index between 18 and 39.9 kg/m2 (normal overweight and obesity grades I and II);do not practice regular physical activity.
Exclusion criteria: Presence of systemic disease that indicate against the practice of physical activity; presence of disabling musculoskeletal disorders; use of drugs that interfere with the hypothalamic-pituitary ovarian axis and hormonal contraceptives; smoking; pregnant.
Age minimum:
18Y
Age maximum:
37Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Polycystic Ovary Syndrome
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C04.182.612.765
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Intervention(s)
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97 women, 45 with polycystic ovary syndrome (PCOS) and 52 healthy women, participated in a linear periodization of physical training for a period of 4 months, three times per week, during 1 hour, preceded by adaptation of 2 weeks or 6 sessions and test dynamic muscle strength of 1 repetition maximum (1-RM).
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G11.427.590.530.698.277
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Procedure/surgery
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Primary Outcome(s)
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1)- Increased muscle strength in all subjects, verified by comparative analysis before and after a period of four months of intervention with the protocol of physical resistance training. - Women with polycystic ovary syndrome, because they are hyperandrogenic, have more muscle strength than women with regular menstrual cycles. - The periodized physical exercise improved body composition and increased telomere length in leukocytes.
2)To measure the outcome, the one repetition maximum (1-RM) test was employed as a noninvasive measure of muscle strength. These test was conducted after two weeks of familiarisation, in which four exercises were performed per day, being separated by two days or 48 hours, for muscle recovery and avoiding influences from other exercises on testing. Body composition was assessed by bone densitometry (X-ray Dual-energy absorptiometry, DXA) and telomere length was measured by Real Time Polymerase Chain Reaction.
3) To investigate outcomes, considering a 10% difference in muscle strength between in groups, with 80% power and alpha = 0.05, 120 participants would be needed, considering previously published studies to muscle strength in young women: bench press = 29.54 ± 5,37kg (mean ± standard deviation); leg extension = 41.09 ± 18,78kg; barbell and 16.00 ± 3.13.
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Secondary Outcome(s)
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1) Body Composition Measurement
2) Body Composition was evaluated by Dual-energy X-ray absorptiometry (DEXA), bioimpedance and skinfold thickness measurement.
3)The periodized physical resistance exercise improved body composition regardless of whether or not the polycystic ovary syndrome (PCOS), and PCOS patients had a reduction of central fat (distribution of gynoide fat)
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1) Quality of life
2) Quality of life was verified by Short Form Health Survey (SF36), Index of Female Sexual Function (IFSF) and Hospital Anxiety and Depression Scale (HADS)
3) After physical resistance training there was an improvement in quality of life, although this benefit has not persisted after discontinuation of training.
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1) Telemere Lenght Measurement
2) Telomere length was measured by Quantitative Real Time Polymerase Chain Reaction (qPCR).
3) Telomere length was reduced after Physical Resistance Training considering all women in the present study, regardless of whether or not the polycystic ovary syndrome (PCOS)
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico
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Fundação de Apoio ao Ensino Pesquisa e Assistência do HCFMRP-USP
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Fundação de Ampara a Pesquisa do Estado de São Paulo
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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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