Effect of PEFLOW on PFM Function Recovery of Postpartum Women
2022年7月6日 更新者：Sun Xiuli、Peking University People's Hospital
Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women
The purpose of this study is to explore the correlation between women's pelvic floor function with their overall state of bodily functions, including body composition, physical activity levels, trunk muscle endurance, body posture, vaginal and gut microbes.
The main intervention of this study is a set of global training which Includes the strength, endurance, flexibility, stability and flexibility training on the diaphragm, abdominal, lower back, as well as pelvic floor muscles, on the basis Kegel training.
The primary destination of global training is to shorten the cycle of postpartum pelvic floor functional recovery, improve the effect of maternal training, and convenient in clinical promotion.
研究概览
地位
招聘中
详细说明
Training for 2 times a week, for 12 weeks leading by a specific physiotherapist.The training intensity was evaluated by RPE self-induced fatigue scale.
研究类型
介入性
注册 (预期的)
260
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xiuli Sun, PHD
- 电话号码：010-88324354
- 邮箱：sunxiuli03351@126.com
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100044
- 招聘中
- The Peking University People's Hospital
-
接触：
- Hongmei ZHU, doctor
- 电话号码：010-88324354
- 邮箱：1209304228@qq.com
-
-
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
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- Newly born women within 42 days to 3 months after delivery, after the end of puerperium, initial postpartum review and pelvic floor professional outpatient screening, found that pelvic floor muscle strength decreased (Oxford Oxford muscle strength ≤ grade 3);
- Healthy before pregnancy without pregnancy complications;
- Convenient transportation, familiar with the Internet;
- Be in good condition and be able to complete the exercise program;
- Complete clinical baseline data;
- Agreed to conduct the study and signed the informed consent.
Exclusion Criteria:
- Patients with stage Ⅲ and Ⅳ pelvic organ prolapse;
- Severe urinary incontinence;
- lochia, vaginal bleeding and pregnancy;
- Serious medical diseases, such as cardiac dysfunction who wear pacemakers, neurological diseases, cognitive impairment and other pathological conditions;
- Cannot complete the intervention program;
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Routine education group
Routine education, including postpartum lifestyle, Kegel exercise and Knack method.
|
Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.
|
|
实验性的：Global training group
Global training was added on the basis of routine education.
|
Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.
Global training was added on the basis of control group.
The 30min-training plan is divided into 9 sections, of which, groups 1 to 8, each group takes about 3 minutes, the ninth group is cool down section, including stretching for 5 minutes and foam axis stretching for 1 minute.
|
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 |
|---|---|---|
|
Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
大体时间：Baseline; After 12 week training or 6th month postpartum
|
The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice.
Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction.
The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.
|
Baseline; After 12 week training or 6th month postpartum
|
|
Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training
大体时间：Baseline; After 12 week training or 6th month postpartum
|
We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
|
Baseline; After 12 week training or 6th month postpartum
|
|
Change from Baseline pelvic floor muscle strength at 1 year postpartum
大体时间：Baseline; 1 year postpartum
|
The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice.
Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction.
The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.
|
Baseline; 1 year postpartum
|
|
Change from Baseline pelvic floor electrophysiology at 1 year postpartum
大体时间：Baseline; 1 year postpartum
|
We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.
|
Baseline; 1 year postpartum
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The occurrence of SUI
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
SUI is defined by SUI symptoms or a positive result of the stress test.
Before the stress test, participants are suggested to keep fully bladder.
Positive result of the stress test is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from Pelvic floor ultrasound indicators
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
LAM thickness, diameter of the levator hiatus and levator hiatus area
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from Pelvic Organ Prolapse Quantitation
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
Pelvic Organ Prolapse Quantitation is measured by callipers
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from Physical activity levels
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
We use International Physical Activity Questionnaire score to measure the overall physical activity level during postpartum period.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from pelvic sagittal rotation degree
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
The quantitative measurement of pelvic sagittal rotation degree on X-ray was analyzed which includes the pelvic tilt angle , the sacral slope angle, the difference of sacral slope and pelvic tilt, the ratio of the pelvic tilt angle to the sacral slope angle, the ratio of the pelvic tilt angle to the pelvic incidence angle and sacral-femoral distance.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from body composition
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
Body composition analysis is measured which mainly includes Body Mass Index（BMI）based on height and weight in kg/m^2.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from body strength
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
Hand grip strength and trunk endurance are measured to describe body strength.
Hand grip strength was measured by JAMAR Plus+ grip gauge.
The measurement accuracy is 0.1kg.
The participants should not have visible hand defects.
The grip gauge should be adjusted before measurement.
When the paticipants holds the grip gauge, the second knuckle of the index finger should be at 90 degrees.
At the same time, mark the best position of each hand on the grip meter.
Before measurement, the participants should remove wrist jewelry to avoid injury.
And the left and right hand are measured alternately for 3 times.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions.The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100.The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from PFIQ-7 Questionnaire Score
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ).To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300.
A lower score means there is a lesser effect on quality of life.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from FSFI-6 Questionnaire Score
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
The 6-item Female Sexual Function Index (FSFI) is a short form of the original 19-item FSFI that measures sexual function in women.It comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Desire and satisfaction items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
|
Change from the Pittsburgh Sleep Quality Index (PSQI) Score
大体时间：Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of scores for these seven components yields one global score.
The 18 items consist of 7 components, and each component is scored according to the grade of 0 ~ 3. The cumulative score of each component is the total score of PSQI, and the total score range is 0~2l.
The higher the score, the worse the sleep quality.
It takes 5 to 10 minutes for the participants to complete the question.
|
Baseline; After 12 week training or 6th month postpartum；1 year follow-up
|
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。
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)
2021年11月2日
初级完成 (预期的)
2023年6月30日
研究完成 (预期的)
2023年6月30日
研究注册日期
首次提交
2021年12月1日
首先提交符合 QC 标准的
2022年1月29日
首次发布 (实际的)
2022年2月1日
研究记录更新
最后更新发布 (实际的)
2022年7月11日
上次提交的符合 QC 标准的更新
2022年7月6日
最后验证
2022年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- PKUPH6
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
(1)Date of disclosure of raw data: December 2023.
Data content: original recorded data and research proposals; (2) Ways or means of sharing IPDs, contact the researchers.
IPD 共享时间框架
2 years
IPD 共享访问标准
contact the researchers
IPD 共享支持信息类型
- 研究协议
- 临床研究报告（CSR）
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
在美国制造并从美国出口的产品
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.