A Prospective Randomized Controlled Trial of MoVo-guided Liuzijue Combined With Traditional Levator Ani Exercise During Pregnancy for Preventing Postpartum Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 135
- 主要终点
- Proportion of participants with urinary incontinence at 42 days postpartum, assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
研究概览
简要总结
The goal of this clinical trial is to determine whether a prenatal exercise program integrating Liuzijue qigong with traditional levator ani training, guided by the MoVo (Motivation-Volition) theory and delivered via a supervised mobile application, can effectively prevent postpartum urinary incontinence and pelvic organ prolapse in pregnant women, compared with app-supervised conventional Kegel exercises and routine prenatal care.
The main questions it aims to answer are:
Does the integrated Liuzijue-and-levator-ani program reduce the incidence of postpartum urinary incontinence and prolapse more effectively than app-supervised Kegel exercises or routine care?
Can the MoVo-based behavioural framework (motivation enhancement, action planning, and self-monitoring) improve long-term adherence to pelvic floor training during pregnancy and the postpartum period?
What are the effects of the three interventions on pelvic floor muscle function, exercise self-efficacy, anxiety levels, and delivery outcomes?
Researchers will compare three parallel groups: (1) the integrated Liuzijue-and-levator-ani exercise group, (2) the app-supervised conventional Kegel exercise group, and (3) the routine care control group receiving only verbal instruction on pelvic floor exercises during standard prenatal visits. All three groups will be followed from enrolment through 6 weeks postpartum to determine whether the culturally adapted mind-body intervention offers superior pelvic floor protection beyond app-delivered Kegel training and routine care.
Participants will:
Be enrolled in the third trimester and randomly assigned to one of the three groups.
In the integrated exercise group, perform daily combined Liuzijue-and-levator-ani exercises via a supervised mobile app and attend periodic check-ins until 6 weeks postpartum.
In the app-supervised Kegel group, perform daily conventional Kegel exercises via the same mobile app platform with the same supervision schedule.
In the routine care group, receive only standard verbal instructions on Kegel exercises during regular antenatal check-ups, without app supervision.
Undergo outcome evaluations at enrolment, before delivery, and at the postpartum follow-up visit, including assessments of urinary incontinence, pelvic organ prolapse, exercise adherence, self-efficacy, anxiety, and any adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 19 years
- •Singleton pregnancy with cephalic presentation；
- •No absolute contraindications to vaginal delivery；
- •No history of urinary incontinence, pelvic organ prolapse, or pelvic floor surgery before pregnancy；
- •Ability and willingness to comply with the full prenatal and postpartum follow-up schedule；
- •Signed written informed consent.
排除标准
- •History of second- or third-trimester miscarriage, recurrent miscarriage, or spontaneous preterm birth；
- •Presence of pregnancy complications, such as severe preeclampsia, fetal distress, placenta previa, placental abruption, or symptoms of threatened preterm labour；
- •Contraindications to exercise, including cervical shortening, cervical insufficiency, or unexplained vaginal bleeding or fluid leakage；
- •Comorbid conditions, such as asthma, cardiovascular disease, hypertension, uncontrolled diabetes mellitus, or thyroid disease；
- •Metabolic bone disease or limited joint mobility；
- •Cognitive or psychiatric disorders that prevent the participant from completing diary records；
- •Concurrent participation in another pelvic floor intervention study.
结局指标
主要结局
Proportion of participants with urinary incontinence at 42 days postpartum, assessed by the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
时间窗: 42 days postpartum
The ICIQ-UI SF is a validated, self-administered questionnaire that evaluates the frequency, volume, and impact of urinary incontinence (UI) over the previous 4 weeks. Total scores range from 0 to 21, with higher scores indicating more severe symptoms. This outcome is defined as the proportion of participants reporting any urine leakage (score ≥1) on the ICIQ-UI SF at the 42-day postpartum follow-up. The chi-square test will be used to compare the incidence of urinary incontinence between the intervention and control groups.
次要结局
- Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate(at 3 months post-intervention)
- Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale.(42 days postpartum)
- Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale(Enrolment, 37 weeks of gestation, 42 days postpartum)
研究者
Yu xin Qian
Researcher
Guangzhou University of Chinese Medicine