Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor in Women in the Postmenopausal Period
2017年5月25日 更新者：Natasha Morena Bazílio Silva、Federal University of Uberlandia
Effects of Physical Training and Isoflavone Supplementation On Pelvic Floor Musculature in Women in the Postmenopausal Period: Controlled Randomized Clinical Trial
This study evaluates the effect of Physical Training and Supplementation of Isoflavone About Pelvic Floor Musculature in Women in the Postmenopausal period, and it has two groups the intervetion.
研究概览
详细说明
The practice of physical exercise and isoflavone supplementation are ways of treating symptoms of climacteric, there is a lack of evidence as to whether these therapeutics when associated are useful for improving the strength, function, contraction pressure, electrical activity of the pelvic floor musculature of women in the Postmenopausal period.
研究类型
介入性
注册 (实际的)
22
阶段
- 第四阶段
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Healthy postmenopausal woman
- to be able to practice exercises on treadmill and weight exercises
- without physical complications that prevent the execution of physical exercises
- have no history of cardiovascular disease, diabetes, renal pathologies or hypertension
- Present ability to contract the pelvic floor muscles
Exclusion Criteria:
- Smokers
- Use hormone therapy or isoflavone
- Use drugs that interfere with lipid and antihypertensive metabolism
- Presence of cognitive impairment or neurological condition that could affect muscle activation
- Present urinary tract infection at the time of data collection
- Training pelvic floor muscle
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group isoflavone and exercise
The isoflavone group received daily 100mg of isoflavones.
|
The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.
每日补充 1 粒胶囊，每天 100 毫克异黄酮（含 3.3% 染料木黄酮、93.5% 大豆苷元和 3.2% 大豆黄酮）。
|
|
安慰剂比较：Group placebo and exercise
The placebo group received 100mg containing starch of corn.
|
The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.
Daily supplementation in 1 capsule per day containing starch of corn.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change vaginal squeeze pressure
大体时间：before and after the intervetion ( 10 weeks)
|
The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity.
The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them.
Outcome Measure of the vaginal squeeze pressure is cmH20 or Pascal.
|
before and after the intervetion ( 10 weeks)
|
|
The change Muscle function
大体时间：before and after the intervetion (10 weeks)
|
"PFM" evaluation was performed by vaginal palpation .During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the "PFM".
Muscle function was classified by the Oxford Scale Modified that five grades of the force.
|
before and after the intervetion (10 weeks)
|
|
The change electromyography pelvic floor
大体时间：before and after the intervetion (10 weeks)
|
"PFM" electromyographic activity was collected during the resting to normalize the EMG data.
No instruction regarding "PFM" contraction was given during the resting of the eight seconds.
After, the volunteers were instructed to perform a maximal voluntary "PFM" contraction with the instruction to move "inward and upward" with the greatest possible force and to hold the contraction for five seconds.
The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them.
|
before and after the intervetion (10 weeks)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Arab AM, Behbahani RB, Lorestani L, Azari A. Correlation of digital palpation and transabdominal ultrasound for assessment of pelvic floor muscle contraction. J Man Manip Ther. 2009;17(3):e75-9. doi: 10.1179/jmt.2009.17.3.75E.
- Pereira VS, Hirakawa HS, Oliveira AB, Driusso P. Relationship among vaginal palpation, vaginal squeeze pressure, electromyographic and ultrasonographic variables of female pelvic floor muscles. Braz J Phys Ther. 2014 Sep-Oct;18(5):428-34. doi: 10.1590/bjpt-rbf.2014.0038. Epub 2014 Oct 10.
- Bo K, Finckenhagen HB. Vaginal palpation of pelvic floor muscle strength: inter-test reproducibility and comparison between palpation and vaginal squeeze pressure. Acta Obstet Gynecol Scand. 2001 Oct;80(10):883-7. doi: 10.1034/j.1600-0412.2001.801003.x.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年9月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2017年3月1日
研究注册日期
首次提交
2017年5月17日
首先提交符合 QC 标准的
2017年5月25日
首次发布 (实际的)
2017年5月30日
研究记录更新
最后更新发布 (实际的)
2017年5月30日
上次提交的符合 QC 标准的更新
2017年5月25日
最后验证
2017年5月1日
更多信息
与本研究相关的术语
其他研究编号
- CEP UFU 52969515.1.0000.5152
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Exercise的临床试验
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的