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NCT Number: NCT06697639

Study on the Effect of WAFF Pelvic and Abdominal Mechanics Exercises During the Puerperium on Postpartum Pelvic Floor Rehabilitation for Parturients

Ethics Review Committee, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Currently, in order to improve women's health throughout their entire life cycle, postpartum rehabilitation for parturients has received significant attention.

Currently, clinical postpartum rehabilitation mostly adopts a combined treatment of Kegel exercises, physical electrical stimulation, and biofeedback therapy. Kegel exercises can be applied during the puerperium. However, studies have found that some parturients find it difficult to locate the muscle contraction sensation during exercise, resulting in poor technique and effectiveness; furthermore, the training process is boring and difficult to maintain. Physical electrical stimulation and biofeedback therapy have significant therapeutic effects, but this treatment should be initiated after the puerperium and requires hospital visits, often leading to discontinuation due to long distances and time-consuming commutes.

Many experts domestically and internationally have stated that earlier postpartum rehabilitation leads to better outcomes. However, studies show that only a small percentage of patients are aware of the correct timing for postpartum rehabilitation and are able to undergo rehabilitation exercises during the puerperium. Most current studies initiate postpartum rehabilitation training from 6 to 8 weeks postpartum, with relatively few reports on pelvic and abdominal muscle training during the puerperium.

Therefore, we have introduced French WAFF pelvic and abdominal mechanical exercises and applied them to the rehabilitation of women during the puerperium. WAFF pelvic and abdominal mechanical exercises are safer, more precise, and more convenient, utilizing the instability created by the WAFF air cushion to stimulate patients' self-regulatory movements, thereby achieving a tighter core and deeper muscle groups to improve training efficiency.

Currently, the application of WAFF pelvic and abdominal mechanical exercises in China is still in the preliminary exploratory stage, and a unified and mature rehabilitation model has not yet been established. This study aims to explore the effectiveness of applying WAFF pelvic and abdominal mechanical exercises during the puerperium to improve postpartum rectus abdominis diastasis and pelvic floor dysfunction. It provides a basis for establishing a new model of puerperium rehabilitation and improving continuous obstetrical nursing.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primipara
  • Singleton pregnancy
  • With full cognitive and behavioral abilities, and voluntarily participating

Exclusion criteria

  • Neonate with a birth weight of >4000g
  • Second-degree or higher perineal tear
  • Poor healing of perineal wounds
  • Individuals with severe hypertension, impaired cardiopulmonary function, and neurological diseases
  • History of previous pelvic floor disorders and urogenital surgeries
  • Individuals engaging in other exercises such as yoga during the puerperium

Treatment and study plan

Rehabilitation Group

Behavioral

In addition to routine postpartum care, small-sized WAFF air cushions will be issued during the hospitalization period to guide patients in performing the WAFF pelvic-abdominal mechanical rehabilitation exercises. Patients will also be instructed to join the experimental group's WeChat group. After discharge, researchers will upload WAFF pelvic-abdominal mechanical rehabilitation instructional videos. Patients are required to complete their rehabilitation exercises twice daily, each session lasting 10-15 minutes. Patients need to upload their exercise videos twice a week, and researchers will provide motion guidance based on the video content until the patient's postpartum follow-up examination. The abdominal rectus muscle, pelvic floor muscle function, and adherence to rehabilitation exercises will be assessed for patients in both groups at 6-8 weeks and 6 months postpartum.

Primary outcomes

  1. "Pelvic floor muscle rehabilitation status"

    Time frame: Prepartum;Postpartum 6-8 weeks

    PFDI-20 Pelvic Floor Distress Inventory score: It consists of a total of 20 questions related to recent bladder, bowel, and pelvic symptoms. Participants are asked to select the degree of impact these symptoms have on their lives. Each selection is scored on a scale of 0 to 4, with a total possible score ranging from 0 to 80. A higher score indicates a greater impact on quality of life.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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