MoVo-guided Traditional Chinese Kegel Exercises for Preventing Postpartum Urinary Incontinence.
A Prospective Randomized Controlled Trial of MoVo-guided Liuzijue Combined With Traditional Levator Ani Exercise During Pregnancy for Preventing Postpartum Urinary Incontinence.
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Yuxin Y Qian
- 電話番号：+8613247548104
- メール：2710559471@qq.com
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：control group
Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision).
|
Routine prenatal care with only verbal instructions on Kegel exercises (no app, no supervision)
|
|
実験的：App-Kegel group
App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).
|
App-supervised daily conventional Kegel exercises (same platform, no Liuzijue/MoVo).
|
|
実験的：TCM comprehensive group
App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.
|
App-supervised daily Liuzijue combined with levator ani training, guided by MoVo theory.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：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.
|
42 days postpartum
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adherence to the antenatal exercise intervention, assessed by exercise diary completion rate
時間枠：at 3 months post-intervention
|
Adherence is evaluated by two combined measures: (1) exercise diary completion rate = (actual number of training sets completed / planned number of training sets) × 100%; and (2) the proportion of participants who perform active training on at least 4 days per week, with each training day defined as completing at least 50% of the planned sets.
The mean adherence rate and the proportion of adherent participants will be reported for the intervention group.
|
at 3 months post-intervention
|
|
Pelvic floor muscle strength assessed by the Modified Oxford Grading Scale.
時間枠：42 days postpartum
|
The Modified Oxford Grading Scale evaluates pelvic floor muscle contraction strength via vaginal palpation, with grades ranging from 0 (no contraction) to 5 (strong contraction).
Median and interquartile range will be reported for each group, and the Mann-Whitney U test will be used for comparison.
|
42 days postpartum
|
|
Change in self-efficacy for pelvic floor exercises, assessed by the Pelvic Floor Exercise Self-Efficacy Scale
時間枠：Enrolment, 37 weeks of gestation, 42 days postpartum
|
The Pelvic Floor Exercise Self-Efficacy Scale is a validated self-report instrument that measures the participant's confidence in adhering to pelvic floor exercise.
Total scores range from 0 to 100, with higher scores indicating greater self-efficacy.
Assessments will be performed at three time points: enrolment, 37 weeks of gestation, and 42 days postpartum.
Mean ± standard deviation of scores and change from baseline will be reported for each group.
Repeated-measures analysis of variance (ANOVA) will be used to compare differences between groups.
|
Enrolment, 37 weeks of gestation, 42 days postpartum
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：ming M Yang、Guangzhou University of Chinese Medicine
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- GDSHLXHYJYB202608
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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