Effect of PEFLOW on PFM Function Recovery of Postpartum Women

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Pelvic Floor Muscle Weakness
• Intervention / Treatment: Behavioral: Active Comparator: Routine education group; Behavioral: Experimental: Global training group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiuli Sun, PHD; Phone Number: 010-88324354; Email: sunxiuli03351@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • The Peking University People's Hospital
      • Contact: Hongmei ZHU, doctor; Phone Number: 010-88324354; Email: 1209304228@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Routine education group; Routine education, including postpartum lifestyle, Kegel exercise and Knack method.	Behavioral: Active Comparator: Routine education group; 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.
Experimental: Global training group; Global training was added on the basis of routine education.	Behavioral: Active Comparator: Routine education group; 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.; Behavioral: Experimental: Global training group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurrence of SUI	SUI is defined by SUI symptoms or a positive result of the stress test. Before the stress test, participants are suggested to keep fully bladder. Positive result of the stress test is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic floor ultrasound indicators	LAM thickness, diameter of the levator hiatus and levator hiatus area	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic Organ Prolapse Quantitation	Pelvic Organ Prolapse Quantitation is measured by callipers	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Physical activity levels	We use International Physical Activity Questionnaire score to measure the overall physical activity level during postpartum period.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from pelvic sagittal rotation degree	The quantitative measurement of pelvic sagittal rotation degree on X-ray was analyzed which includes the pelvic tilt angle , the sacral slope angle, the difference of sacral slope and pelvic tilt, the ratio of the pelvic tilt angle to the sacral slope angle, the ratio of the pelvic tilt angle to the pelvic incidence angle and sacral-femoral distance.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from body composition	Body composition analysis is measured which mainly includes Body Mass Index（BMI）based on height and weight in kg/m^2.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from body strength	Hand grip strength and trunk endurance are measured to describe body strength. Hand grip strength was measured by JAMAR Plus+ grip gauge. The measurement accuracy is 0.1kg. The participants should not have visible hand defects. The grip gauge should be adjusted before measurement. When the paticipants holds the grip gauge, the second knuckle of the index finger should be at 90 degrees. At the same time, mark the best position of each hand on the grip meter. Before measurement, the participants should remove wrist jewelry to avoid injury. And the left and right hand are measured alternately for 3 times.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score	The Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20) is the short-form version of the Pelvic Floor Distress Inventory (PFDI).Since it is comprised of the UDI-6, POPDI-6, and the CRADI-8, the PFDI-20 includes 20 questions.The scale scores are found individually by calculating the mean value of their corresponding questions and then multiplying by 25 to obtain a value that ranges from 0 to 100.The sum of the 3 scales are added together to get the PFDI-20 summary score, which ranges from 0 to 300.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from PFIQ-7 Questionnaire Score	The Pelvic Floor Impact Questionnaire-7 (PFIQ-7) is a shortened, less comprehensive version of the Pelvic Floor Impact Questionnaire (PFIQ).To get scale scores, the mean of each of the 3 scales is individually calculated, which ranges from 0-3, this number is then multiplied by 100 and then divided by 3.The scale scores are then added together to get the total PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from FSFI-6 Questionnaire Score	The 6-item Female Sexual Function Index (FSFI) is a short form of the original 19-item FSFI that measures sexual function in women.It comprises six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Desire and satisfaction items are rated on a 5-point Likert scale, ranging from 1 to 5, and the other items are rated on a 6-point Likert scale, ranging from 0 to 5. Total scores range from 2 to 30, with lower scores indicating worse sexual functioning.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from the Pittsburgh Sleep Quality Index (PSQI) Score	The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The 18 items consist of 7 components, and each component is scored according to the grade of 0 ~ 3. The cumulative score of each component is the total score of PSQI, and the total score range is 0~2l. The higher the score, the worse the sleep quality. It takes 5 to 10 minutes for the participants to complete the question.	Baseline; After 12 week training or 6th month postpartum；1 year follow-up

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: January 29, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; postpartum; global training; pelvic floor muscle
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: PKUPH6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: (1)Date of disclosure of raw data: December 2023. Data content: original recorded data and research proposals; (2) Ways or means of sharing IPDs, contact the researchers.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: contact the researchers
• IPD Sharing Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No