Study on the Effect of WAFF Pelvic and Abdominal Mechanic... | NCT06697639

Status Module

Description Module

Brief Summary

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.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rehabilitation Group	Experimental	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.	Behavioral: Rehabilitation Group
Control Group	No Intervention	During hospitalization, routine postpartum education and discharge instructions will be provided, including the distribution of promotional brochures and guidance on performing puerperium recovery exercises. Patients will be instructed to join the control group's WeChat group. After discharge, researchers will upload instructional videos for the recovery exercises and urge patients to perform the postpartum recovery exercises twice daily, each session lasting 10-15 minutes. Patients are required 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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
"Pelvic floor muscle rehabilitation status"	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.	Prepartum；Postpartum 6-8 weeks

Eligibility Module