MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.

Официальное название

A Prospective Randomized Controlled Trial of MoVo-guided Liuzijue Combined With Traditional Levator Ani Exercise During Pregnancy for Preventing Postpartum Urinary Incontinence.

Обзор

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.

Вмешательства

• Поведенческое Routine Verbal Instruction Group
  Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision)
• Поведенческое App-Supervised Kegel Exercise Group
  App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).
• Поведенческое Liuzijue & Levator Ani Training Group
  App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.

Первичные конечные точки

• 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) [Срок оценки: 42 days postpartum]

Вторичные конечные точки (3)

• Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate [Срок оценки: at 3 months post-intervention]
• Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale. [Срок оценки: 42 days postpartum]
• Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale [Срок оценки: Enrolment, 37 weeks of gestation, 42 days postpartum]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07742202 · GDSHLXHYJYB202608

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗