Clinical trial NCT05218239: Effect of PEFLOW on PFM Function Recovery of Postpartum Women
Official title: Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Floor Muscle Weakness
Rehabilitation
Keywords: postpartum
global training
rehabilitation
pelvic floor muscle
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2022-02-01
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the correlation between women's pelvic floor function with their overall state of bodily functions, including body composition, physical activity levels, trunk muscle endurance, body posture, vaginal and gut microbes. The main intervention of this study is a set of global training which Includes the strength, endurance, flexibility, stability and flexibility training on the diaphragm, abdominal, lower back, as well as pelvic floor muscles, on the basis Kegel training. The primary destination of global training is to shorten the cycle of postpartum pelvic floor functional recovery, improve the effect of maternal training, and convenient in clinical promotion.

Detailed description: Training for 2 times a week, for 12 weeks leading by a specific physiotherapist.The training intensity was evaluated by RPE self-induced fatigue scale.

Eligibility criteria: Inclusion Criteria:

* Newly born women within 42 days to 3 months after delivery, after the end of puerperium, initial postpartum review and pelvic floor professional outpatient screening, found that pelvic floor muscle strength decreased (Oxford Oxford muscle strength ≤ grade 3);
* Healthy before pregnancy without pregnancy complications;
* Convenient transportation, familiar with the Internet;
* Be in good condition and be able to complete the exercise program;
* Complete clinical baseline data;
* Agreed to conduct the study and signed the informed consent.

Exclusion Criteria:

* Patients with stage Ⅲ and Ⅳ pelvic organ prolapse;
* Severe urinary incontinence;
* lochia, vaginal bleeding and pregnancy;
* Serious medical diseases, such as cardiac dysfunction who wear pacemakers, neurological diseases, cognitive impairment and other pathological conditions;
* Cannot complete the intervention program;

Primary outcomes:
measure: Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
timeFrame: Baseline; After 12 week training or 6th month postpartum
measure: Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training
timeFrame: Baseline; After 12 week training or 6th month postpartum
measure: Change from Baseline pelvic floor muscle strength at 1 year postpartum
timeFrame: Baseline; 1 year postpartum
measure: Change from Baseline pelvic floor electrophysiology at 1 year postpartum
timeFrame: Baseline; 1 year postpartum
Secondary outcomes:
measure: The occurrence of SUI
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from Pelvic floor ultrasound indicators
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from Pelvic Organ Prolapse Quantitation
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from Physical activity levels
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from pelvic sagittal rotation degree
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from body composition
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from body strength
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from PFIQ-7 Questionnaire Score
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from FSFI-6 Questionnaire Score
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
measure: Change from the Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Study Chair
name: Xiuli Sun, PHD
role: STUDY_CHAIR
References:
citation: Zhu H, Zhang D, Gao L, Liu H, Di Y, Xie B, Jiao W, Sun X. Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women: Protocol for a Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Sep 4;19(17):11073. doi: 10.3390/ijerph191711073.