Effect of PEFLOW on PFM Function Recovery of Postpartum Women

NCT05218239 | Unknown DMC

• 1 other identifier: PKUPH6
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Muscle Weakness; Rehabilitation

Keywords

postpartum; global training; rehabilitation; pelvic floor muscle

Outcome Measures

Primary Outcomes (4)

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

  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.

  Baseline; After 12 week training or 6th month postpartum

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

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

  Baseline; After 12 week training or 6th month postpartum

• Change from Baseline pelvic floor muscle strength at 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.

  Baseline; 1 year postpartum

• Change from Baseline pelvic floor electrophysiology at 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.

  Baseline; 1 year postpartum

Secondary Outcomes (11)

• The occurrence of SUI

  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 Pelvic Organ Prolapse Quantitation

  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

• Change from pelvic sagittal rotation degree

  Baseline; After 12 week training or 6th month postpartum；1 year follow-up

Study Arms (2)

Routine education group

ACTIVE COMPARATOR

Routine education, including postpartum lifestyle, Kegel exercise and Knack method.

Behavioral: Active Comparator: Routine education group

Global training group

EXPERIMENTAL

Global training was added on the basis of routine education.

Behavioral: Active Comparator: Routine education group; Behavioral: Experimental: Global training group

Interventions

Active Comparator: Routine education group BEHAVIORAL

Behavior guidance on pelvic floor muscle function training , including Knack method education , and Kegel exercise and other pelvic floor muscle training methods were taught to postpartum women.

Global training group; Routine education group

Experimental: Global training group BEHAVIORAL

Global training was added on the basis of control group. The 30min-training plan is divided into 9 sections, of which, groups 1 to 8, each group takes about 3 minutes, the ninth group is cool down section, including stretching for 5 minutes and foam axis stretching for 1 minute.

Global training group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University: collaborator

Study Sites (1)

The Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36078788 DERIVED

Study Officials

• Xiuli Sun, PHD

  Study Chair

  STUDY CHAIR

Central Study Contacts

Xiuli Sun, PHD

CONTACT

010-88324354; sunxiuli03351@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor; chief physician

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: February 1, 2022
• Study Start: November 2, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2 years
• Access Criteria: contact the researchers

Locations

CN (1)