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Clinical Trials/NCT05218239
NCT05218239
Unknown
Not Applicable

Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women

Peking University People's Hospital1 site in 1 country260 target enrollmentNovember 2, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Floor Muscle Weakness
Sponsor
Peking University People's Hospital
Enrollment
260
Locations
1
Primary Endpoint
Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2021
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sun Xiuli

professor; chief physician

Peking University People's Hospital

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;

Outcomes

Primary Outcomes

Change from Baseline pelvic floor muscle strength at 6 months or after 12 weeks training

Time Frame: Baseline; After 12 week training or 6th month postpartum

The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction. The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.

Change from Baseline pelvic floor electrophysiology at 6 months or after 12 weeks training

Time Frame: Baseline; After 12 week training or 6th month postpartum

We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.

Change from Baseline pelvic floor muscle strength at 1 year postpartum

Time Frame: Baseline; 1 year postpartum

The participants were instructed to contract the pelvic floor muscle correctly and allowed for one practice. Three times of maximum contraction holding for five seconds with an interval resting of five seconds were performed, and the maximum value among three was recorded as the muscle strength of maximal voluntary contraction. The result was recorded using the modified Oxford Grading scale, ranging from 0 to 5, which 0 represents no discernible pelvic floor muscle contraction and 5 represents a strong pelvic floor muscle contracion.

Change from Baseline pelvic floor electrophysiology at 1 year postpartum

Time Frame: Baseline; 1 year postpartum

We use Urostym to measure pelvic floor muscle strength which can identity the strength between Type I muscle fibers and Type II muscle fibers.

Secondary Outcomes

  • Change from Pelvic Organ Prolapse Quantitation(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from body composition(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from Pelvic floor ultrasound indicators(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from Physical activity levels(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • The occurrence of SUI(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from FSFI-6 Questionnaire Score(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from pelvic sagittal rotation degree(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from body strength(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from Pelvic Floor Distress Inventory(PFDI-20)Questionnaire Score(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from PFIQ-7 Questionnaire Score(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)
  • Change from the Pittsburgh Sleep Quality Index (PSQI) Score(Baseline; After 12 week training or 6th month postpartum;1 year follow-up)

Study Sites (1)

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