Ijerph 19 11073

International Journal of
Environmental Research
and Public Health
Protocol
Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function
Recovery of Postpartum Women: Protocol for a Randomized
Controlled Trial
Hongmei Zhu 1,2,3 , Di Zhang 1,3 , Lei Gao 1,3 , Huixin Liu 1,3 , Yonghui Di 2 , Bing Xie 1,3 , Wei Jiao 2, *,†
and Xiuli Sun 1,3, *,†
1 Department of Obstetrics and Gynecology, Peking University People’s Hospital, No. 11,
Xi-Zhi-Men South Street, Xi Cheng District, Beijing 100044, China
2 Department of Sports medicine and rehabilitation, Beijing Sports University, No.48, Xin Xi Road,
Hai Dian District, Beijing 100084, China
3 The Key Laboratory of Female Pelvic Floor Disorders, Beijing 100044, China
* Correspondence: [email protected] (W.J.); [email protected] (X.S.)
† These authors contributed equally to this work.
Abstract: Background: There is a risk of pelvic floor dysfunction (PFD) from baby delivery. Many
clinical guidelines recommend pelvic floor muscle training (PFMT) as the conservative treatment for
PFD because pelvic floor muscles (PFMs) play a crucial role in development of PFD. However, there
is disagreement about the method and intensity of PFM training and the relevant measurements.
To pilot the study in PFM training, we designed a Pelvic Floor Workout (PEFLOW) for women to
Citation: Zhu, H.; Zhang, D.; Gao, L.; train their pelvic through entire body exercises, and we planned a trial to evaluate its effectiveness
Liu, H.; Di, Y.; Xie, B.; Jiao, W.; Sun, X. through comparing the outcomes from a group of postpartum women who perform PELFLOW at
Effect of Pelvic Floor Workout on home under professional guidance online with the control group. Methods/design: The randomized
Pelvic Floor Muscle Function controlled trial was projected to be conducted from November 2021 to March 2023. A total of
Recovery of Postpartum Women:
260 postpartum women would be recruited from the obstetrics departments of the study hospital
Protocol for a Randomized
and women would be eligible for participation randomized into experimental or control groups
Controlled Trial. Int. J. Environ. Res.
(EG/CG) if their PFM strength are scaled by less than Modified Oxford grading Scale (MOS) to be less
Public Health 2022, 19, 11073.
than grade 3. Women in EG would perform a 12-week PEFLOW online under the supervision and
https://doi.org/10.3390/
ijerph191711073
guidance of a physiotherapist, while women in CG would have no interventions. Assessments would
be conducted at enrollment, post intervention (for EG) or 18th to 24th week postpartum (for CG), and
Academic Editors: Milan Terzic,
1 year postpartum. Assessment would be performed in terms of pelvic floor symptoms, including
Antonio Simone Laganà,
MOS, cough stress test, urinary leakage symptoms, pelvic organ prolapse quantitation (POP-Q), and
Antonio Sarria-Santamera and
vaginal relaxation, clinic examinations including Pelvic floor electrophysiological test, Pelvic floor
Ugo Indraccolo
ultrasound and Spine X-ray, overall body test including trunk endurance test, handgrip test, body
Received: 6 July 2022 composition test, and questionnaires including International Physical Activity Questionnaire Score-
Accepted: 2 September 2022 Short Form(IPAQ-SF), Pelvic Floor Distress Inventory Questionnaire-20 (PFDI-20), Pelvic Floor Impact
Published: 4 September 2022
Questionnaire-7 (PFIQ-7), the 6-item Female Sexual Function Index (FSFI-6), and the Pittsburgh Sleep
Publisher’s Note: MDPI stays neutral Quality Index (PSQI). Primary analysis will be performed to test our main hypothesis that PEFLOW
with regard to jurisdictional claims in is effective with respect to strengthen PFM strength. Discussion: This trial will demonstrate that
published maps and institutional affil- pelvic floor-care is accessible to most women and clinical practice on PFD may change relevantly
iations. should this study find that Online PEFLOW approach is effective to improve PFMs. Trial registration:
ClinicalTrials.gov, NCT05218239.
Keywords: pelvic floor muscle training; pelvic floor workout; pelvic floor muscle; pelvic floor
Copyright: © 2022 by the authors.
dysfunction; postpartum; rehabilitation
Licensee MDPI, Basel, Switzerland.
This article is an open access article
distributed under the terms and
conditions of the Creative Commons
Attribution (CC BY) license (https://
1. Introduction/Background
creativecommons.org/licenses/by/ Pelvic floor dysfunction (PFD) is a series of symptoms of dysfunction caused by
4.0/). injuries on pelvic floor muscle, nerve, ligament, and fascia injury. PFD has a serious
Int. J. Environ. Res. Public Health 2022, 19, 11073. https://doi.org/10.3390/ijerph191711073 https://www.mdpi.com/journal/ijerph
Int. J. Environ. Res. Public Health 2022, 19, 11073 2 of 14
negative impact on the common life of woman, who would experience different degrees of
urinary incontinence, pelvic organ prolapse, chronic pelvic pain, sexual dysfunction, etc.
Although not clinically emergent, PFD brings a heavy economic burden to the women
who suffers from this problem. The latest updated data show that the prevalence of
urinary incontinence in Chinese women reaches 30.9%, the incidence of symptomatic
pelvic organ prolapse is up to 9.6% [1], and the prevalence of sexual dysfunction is
about 29.7% [2]. Pelvic floor diseases are more prevalent among women who have
multiple births.
Pregnancy and vaginal delivery have independently been proved to be the risk factors
for the development of severe urinary incontinent (SUI) as they could obviously weaken
the pelvic floor muscle (PFM) strength. However, it was hard to evaluate patients’ muscle
strength objectively; therefore, it was hard to validate whether a measure could be effective
to have the weakened pelvic floor muscles be recovered before Modified Oxford scale
(MOS) for muscle strength was published [3]. MOS provides quantitative scales for muscle
strength, and it is simple and easy to apply clinically. It is becoming widely accepted
method for pelvic floor muscle strength assessment since it was published. Literately and
clinically, MOS 4 and 5 is identified as having “good” or “strong” muscle contraction which
represents a normal condition of the pelvic floor muscles; relevantly MOS ≤3 indicates a
weak contraction or no contraction being felt [4]. Some studies suggested that pelvic floor
muscle strength be correlated with the incidence of pelvic organ prolapse (POP). Thus,
Pelvic Organ Prolapse Quantification (POP-Q) was developed for evaluation of the pelvic
floor muscle [5]. Borello-France et al. [6] used POP-Q to evaluated women’s pelvic floor
muscle in their studies and argued that women with stage II of prolapse were better than
those with stage III or IV in elevating their pelvic floor, and also would be easier to get
benefit from PFM training than those over stage III. Scientific evidence showed that 10–20%
of patients who were not intervened for the clinically confirmed POP got progressed in
term of POP-Q scoring in 2-year follow-up [7,8], so early prevention or treatment should
have high priority. The incidence rate of POP is higher in middle aged and elderly women.
PFM training is recommended to women postpartum for it reduces the incidence of PFD
during 6–12 months postpartum [9] and should possibly reducing the incidence of diseases
from muscle dysfunction related to the anatomical changes with aging [10]. A program of
supervised PFM training was recommended as a first option for women with symptomatic
POP-Q stage I or stage II [11]. MOS and POP-Q can be the objective indicators be used to
validate the effectiveness of any measure in improving PFM.
PFM training is the most popular conservative intervention for PFD. Its role in PFM
improvement is becoming more and more important along with the rapid development of
rehabilitation medicine and it is more and more acceptable by women as their requirements
for improvement of quality of life are getting stronger. There are many kinds of programs
for post-delivery exercises that are commercially available for women. Formulating a
rehabilitation program after childbirth is certainly an effective strategy for most women
to benefit from the post-delivery recovery. However, PFM rehabilitation relied on the
synchronous recovery of both type I and type II muscle fibers, and, as it is difficult to
identify type I and type II of the muscle fibers accurately by nonprofessionals during
pelvic floor muscle contraction, exercises are usually not properly programmed, and
the effectiveness of such programs are not easy to gain. Formulating a science-based
rehabilitation program that can trained type I and type II muscle fibers for their synchronous
rehabilitation after childbirth is certainly an effective strategy for most women to benefit
from the post-delivery recovery.
Many pelvic floor rehabilitation methods were explored in previous studies. In 1948,
Kegel training was first proposed and adopted as the gold standard of pelvic floor muscle
training (PFMT) [12]. PFMT refers to the conscious exercise via autonomic contraction
of the pelvic floor muscles that are dominated by pubococcinate muscles. The American
Urogynecologic Society evaluated PFMT as the wisest exercise choice for women and
recommended it as the first-line treatment for PFD [13]. Kegel exercise has rarely been
used alone until now. The human body is an organic whole, so PFMT should not be
limited to the local pelvic floor. In 1980, abdominal hypopressive technique (AHT) [14] was
invented. It emphasizes PFMT to be combined with activation of transverse abdominis
muscle and diaphragmatic breathing [14]. Some studies found that training of the core
muscles, including rectus abdominis, transversus abdominis, internal or external oblique,
lumbar multifidus, and erector spinae muscles [15] for their stability, such as Yoga exercises,
can strengthen PFM [16,17]. A French therapist, Philippe, proposed a concept of Global
Postural Re-education (GPR) [18,19] and demonstrated that GPR was advantageous in
improving respiratory muscle strength and reducing urinary incontinence since GPR
was projected to correct postural misalignments by stretching the muscle chains [19]. In
consideration that the spine is a continuous boney structure that is closely associated with
pelvic dynamics [20], some investigators in recent years focused their research on restoring
the balance of anatomic mechanical systems through adjustment of the posture. It was
found that therapeutic exercise on posture adjustment (diaphragm and lumbar position)
for patients with poor respiration and posture can improve the neuromuscular control
on muscles of deep abdomen, diaphragm, and pelvic floor, and promote the stability of
lumbar and pelvic floor. In addition, a significant correlation between overall posture and
PFD was also demonstrated in several studies [20,21].
In 2020, the Canadian Society of Obstetricians and Gynecologists (SOGC) recom-
mended that, to gain effectiveness, PFMT should be performed under supervision for at
least 3 months [22]. Some previous studies [23–26] in alleviation of symptomatic ureter leak-
age demonstrated that physical exercise with PFMT was effective on the pelvic floor muscle.
In referring to the above published studies and concepts and based on the previous
study [27] of our team, our team from Peking University Peoples Hospital (PKUPH)
developed a Pelvic Floor Workout (also named as PKUPH-PEFLOW), which focuses on
training to improve the strength, endurance, flexibility, stability, and flexibility of core
muscles, including diaphragmatic, abdominal, pelvic floor, and lower back muscles. We
also designed a randomized controlled clinical trial to demonstrate the effectiveness of
PEFLOW. The trial was designed on hypothesis that (1) a 12-week Global Pelvic Floor
Workout would improve the pelvic floor muscle strength of postpartum women; (2) the
12-week Global Pelvic Floor Workout would positively impact on the overall function of
postpartum women, including pelvic floor function, body posture, pain, etc.; and (3) body
posture, physical activity level, trunk muscle endurance and strength would have beneficial
effects on maternal overall function.
2. Methods
2.1. Study Design
This is a randomized controlled trial to be conducted from November 2021 to March
2023. Participants are recruited from the obstetrics departments of Peking University
People’s Hospital. The study was approved by Peking University Institutional Re-
view Board (number: 2021PHB254-001) and registered in Clinical.Trials.gov (number:
NCT05218239).
2.2. Inclusion Criteria

Postpartum women will be eligible for enrollment if they are: (1) in 6th to 12th
week postpartum; (2) without history of clinically confirmed systematic diseases, such as
neurological conditions and cardiac insufficiency, currently not wearing cardiac pacemaker
or receiving hormone therapy, and/or not been treated with radical surgery for pelvis
and sling or surgery for prolapse before pregnancy, and with no pregnant complications;
(3) willing to participate signing informed consent form; and (4) able to read without
cognitive problem from poor education or diagnosed mental problem.
2.3. Exclusion Criteria

Participants will be excluded if they are: (1) confirmed by postpartum pelvic exam-
ination to be >grade 3 of pelvic floor muscle strength by Modified Oxford Scale (MOS);
(2) ≥stage III for Pelvic Organ Prolapse Quantification (POP-Q); (3) symptomatically con-
firmed to have severe urinary incontinence (Women with more than one incontinent episode
per day AND an important volume of urine loss [28] or urine leakage occurred in a quiet
state were classified as having severe urinary incontinence); or (4) any limb dysfunction
that unenabled women to take this training. A participant will be recorded as“ drop off
from trial” if she becomes pregnant during the follow-ups.
2.4. Site Investigators and Roles

To conduct and evaluate the project, the study should assign the following persons to
play roles: (1) a gynecologist (can be the chief investigator) who would conduct baseline
examination and evaluation for eligible women, and another two gynecologists who would
conduct examinations at the second and third follow-up visits, respectively, who was
unaware of the data from the last follow-up. The examinations would include MOS,
POP-Q, cough stress test, and vaginal relaxation.
(2) A research coordinator who is responsible for informed consent, study record and
data management, contacting with and be accompanied with the participants during the
examinations.
(3) A physiotherapist who would apply the designed intervention to participant in
experimental group (EG).
(4) A physiotherapist assistant who would be responsible for correcting actions of
EG during training and record Borg’s Rating of Perceived Exertion 6-20 (RPE) Scale after
each session of training. (5) Clinic examiners who would be responsible for pelvic floor
surface electromyography (sEMG), pelvic floor ultrasound examination, and Spine X-ray.
2.5. Randomization and Allocation Concealment

Eligible women would be randomized into two groups, the experimental group (EG)
and the control group (CG), at a ratio of 1:1. A randomization list would be created
by a statistician from Peking University for each center before the start of the research.
Randomization would be performed using SAS 9.4 (SAS Institute, Cary, NC, USA). The
randomization lists would be concealed until a woman is confirmed eligible for partic-
ipation. Then, the research coordinator in the site would assign the eligible participant
to EG or CG. With such a randomization, the numbers of participants in EG and CG are
expected to be statistically balanced. Participants and the physiotherapists engaging in the
intervention are not blind to the randomized assignment because it is not feasible to do.
However, to minimize the risk of assessor’s unblinding, participants are blind to other’s
assignments and encouraged not to discuss their treatment with the independent assessor
in the informed consent procedures and at the time of each assessment.
2.6. Assessment Schedule

Each participant would experience three assessments to go through the whole pro-
cedures in this study. The first assessment is for enrollment and would be given when
women is confirmed eligible for participation. The second assessment would be conducted
after 18th week postpartum but not later than 24th week. The final assessment would be
performed in one year after delivery (Figure 1).
Int. J. Environ. Res. Public Health 2022, 19, x FOR PEER REVIEW 5 of 14
Figure 1.1.Flowchart
Figure Flowchartofofthe
thetrial.
trial.
2.7. Interventions
2.7. Interventions
All participants in EG and CG would be undergo postpartum pelvic floor evaluation
All participants
according to standard incomical
EG andprocedures,
CG would whichbe undergo
includespostpartum
instructions pelvic floor
for PFM evaluation
strengthen-
according
ing with Kegel [12] and Knack [29] methods to improve voluntary contraction of thestrength-
to standard comical procedures, which includes instructions for PFM pelvic
ening
floorwith Kegel
muscles, [12] and
as well Knack
as daily [29]
living methods
habits to improve
and posture voluntary
education, contraction
such as of the
reducing stool
pelvic floor muscles, as well as daily living habits and posture education,
time, avoiding heavy lifting, etc. No extra intervention would be given to the participants such as reducing
stool time, avoiding heavy lifting, etc. No extra intervention would be given to the partic-
in CG.
ipants In
in addition
CG. to the clinical standard pelvic floor evaluation, participants in EG would
be In
provided
addition with
to thea Pelvic Floor
clinical Workout
standard (PEFLOW).
pelvic PEFLOW
floor evaluation, is a general
participants inprogram
EG would
for physical training of the pelvic floor via entire body
be provided with a Pelvic Floor Workout (PEFLOW). PEFLOW is a general programexercise. PEFLOW trains onfor
coordination of breathing and muscle movement, maximum contraction
physical training of the pelvic floor via entire body exercise. PEFLOW trains on coordina- of PFM, quick
contraction
tion of breathingof the
andPFM,muscle andmovement,
enduring contraction of PFM. The
maximum contraction of frequency
PFM, quickofcontraction
exercise
offollowing
the PFM,PEFLOW
and enduring is 2 sessions a week
contraction for 12The
of PFM. weeks. It should
frequency be performed
of exercise under
following PE-
the guidance of the professional physiotherapist for the whole process. It is designed
FLOW is 2 sessions a week for 12 weeks. It should be performed under the guidance of
for offline and online exercise. Due to COVID-19 pandemic prevention, PEFLOW in this
the professional physiotherapist for the whole process. It is designed for offline and online
study would be performed by the participants in EG at home under the online guidance of
exercise. Due to COVID-19 pandemic prevention, PEFLOW in this study would be per-
2 physiotherapists. In order to keep the training effective, we would conduct the training
formed by the [26]
in grouping participants
with eachinincluding
EG at home lessunder
than 10thepersons
online guidance
and ensure ofthat
2 physiotherapists.
no woman is
Inover
order to 12
than keep
weeksthe postpartum
training effective, wesession
at her first wouldofconduct
PEFLOW. the training in grouping [26]
with each
The including less than 10 personsPEFLOW
Physiotherapist-online-guided and ensure that no woman
(OG-PEFLOW) is over
would than 12 weeks
be performed by
postpartum at her first session of PEFLOW.
participants in EG twice sessions a week for 12 weeks (Figure3). OG-PEFLOW would be
The Physiotherapist-online-guided PEFLOW (OG-PEFLOW) would be performed by
participants in EG twice sessions a week for 12 weeks (Figure3). OG-PEFLOW would be
provided via Zoom and in the form of live broadcasting. To monitor the performance of
provided via Zoom and in the form of live broadcasting. To monitor the performance of the
participants, the participants would be requested to turn on the camera on their playing
devices during the whole sessional procedures; however, they would be fully informed
that no video or picture would be recorded or shot to protect their privacy. In each session
of the OG-PEFLOW, a physiotherapist would perform exercise guidance, while another
physiotherapist would monitor the performance of the participants and take notes. Details
of the PEFLOW will be published in another manuscript.
During the 12 weeks of intervention, participants in EG group would be requested
to record their training load using RPE scale [30] every time after each training session.
RPE quantitative evaluation of exercise load is calculated by “RPE score times x Exercise
duration”. RPE scale indicates the exercise intensity in a specific time and the participants’
subjective psychological response to the stimulation from the exercise loads. In addition,
Both EG and CG needs to record their training or exercise (if any) from the 6th week to
1 year postpartum. All of those records would be used for post-intervention assessment
after 12-week intervention of EG.
The PEFLOW (Tables 1 and 2) is a multimodal exercise program including moderate-
intensity, aerobic, resistance, balance, and stretching exercise combined with PFMT, and the
duration of each training session is about 60 min. Included in this program are ten sections,
one for pelvic floor warm-up, eight for global exercises, and one for cooling down.
All participants in EG are informed to claim to the medical providers involved if any
experiencing symptoms related to sport injury (e.g., knee pain, elbow pain, etc.). Any
patients claiming to have such injury would be referred to the obstetric department or the
physio therapist for treatment followed by an assessment for whether they should continue
the training or not. An anticipated adverse event log would be prepared and sent to the
principal investigator (PI) when such injury happens.
Table 1. The 12-week Pelvic Floor Workout and the sectioning.
Week 8-Scetion Program Week 8-Scetion Program

Pelvic floor perception, try to feel the contraction of pelvic floor muscles at different positions, including standing, lying and
Warm-ups
sitting position.
1. Walking squeezing
2. Sitting on Swiss ball: pelvic with
up-limb dancing
1. Standing squeezing
3. Lying: new respiratory exercise
2. Sitting on Swiss ball: pelvic dancing
with balloon
4. Lying: hip isometric curling with balloon
4. Lying: hip curling
1 7 5. Lying with neck bending: leg clip ball+
5. Lying: dynamic hand-knee resistance
isometric hand-ball resistance
6. Side lying: knee bending side bridge
6. Side lying: knee extension isometric
7. Lying: alternating knee extension
side bridge
8. Four-foot kneeling: alternating
7. Lying: four-foot dynamic extension with
knee extension
elastic belt
8. Four-foot kneeling: four-foot dynamic
Main extension with elastic belt
Progressive 1. Walking squeezing
Exercises 2. Sitting on Swiss ball: pelvic with
up-limb dancing
1. Standing squeezing
with balloon
4. Lying: Hip isometric curling with
4. Lying: hip curling
balloon
2 5. Lying: dynamic hand 8 5. Lying with neck bending: leg clip ball+
-knee resistance
isometric hand-ball resistance
6. Side lying: knee bending side bridge
6. Side lying: knee extension isometric
7. Lying: four-foot dynamic extension
side bridge
8. Four-foot kneeling: four-foot
dynamic extension
elastic belt
8. Four-foot kneeling: four-foot isometric
extension with elastic belt
Table 1. Cont.
Week 8-Scetion Program Week 8-Scetion Program

1. Walking squeezing +Arm large swing
2. Sitting on Swiss ball: pelvic with up-limb
1. Calf raising squeezing
dancing using elastic belt
with balloon
4. Lying: Hip curling
4. Lying: hip isometric curling with balloon
5. Lying with neck bending: dynamic
3 9 5. Lying: neck bending +Leg Clip Ball+
hand -knee resistance
Side ball shot
6. Side lying: knee bending “clam”
6. Side lying: knee extension side bridge
side bridge
with arm cross swing
7. Lying: four-foot dynamic extension
elastic belt
dynamic extension
extension with elastic belt
1. Walking squeezing +Arm large swing
dancing using elastic belt
1. Calf raising squeezing
with balloon
4. Lying: hip dynamic curling with Swiss
4. Lying: hip curling with balloon
ball and balloon
5. Lying with neck bending: dynamic
4 10 5. Lying with neck bending: Leg Clip Ball+
hand -knee resistance
Side ball shot
6. Side lying: knee bending clam
6. Side lying: knee extension side bridge
side bridge
with arm cross swing
7. Lying: four-foot isometric extension
7. Side Lying: Four-foot isometric extension
with elastic belt
isometric extension
extension with elastic belt on
Main
unstable support
Progressive
Exercises 1. Walking squeezing with arm small swing
1. Single leg squeezing dancing using elastic belt
2. Sitting on Swiss ball: pelvic and 3. Lying: new respiratory exercise
up-limb dancing with balloon
3. Lying: new respiratory exercise 4. Lying: hip dynamic curling with Swiss
4. Lying: hip curling with balloon ball and balloon
5 5. Lying with neck bending: isometric 11 5. Lying with neck bending: leg clip ball+
hand -knee resistance side ball shot
6. Side lying: knee extension dynamic 6. Side lying: four-foot extension
side bridge side bridge
7. Lying: four-foot isometric extension 7. Lying: four-foot isometric extension with
8. Four-foot Kneeling: four-foot elastic belt
isometric extension 8. Four-foot kneeling: four-foot isometric
unstable support
1. Walking squeezing with Arm
small swing
1. Single leg squeezing dancing using elastic belt
2. Sitting on Swiss ball: pelvic and 3. Lying: new respiratory exercise
up-limb dancing with balloon
3. Lying: new respiratory exercise 4. Lying: hip dynamic curling with Swiss
4. Lying: hip curling with balloon ball and balloon
6 5. Lying with neck bending: isometric 12 5. Lying with neck bending: leg clip ball+
hand -knee resistance side ball shot
6. Side Lying: knee extension dynamic 6. Side lying: four-foot extension side
side bridge bridge with upper leg abducted (if not,
7. Lying: four-foot isometric extension the same as week 11th)
8. Four-foot Kneeling: four-foot 7. Lying: four-foot isometric extension with
dynamic extension with elastic belt elastic belt
unstable support
Dynamic stretching, including upper and lower limbs, waist, back, and abdomen stretching and pelvic floor muscle relaxation
Cooling Down
with mini foam axis.
sion upper leg abducted (if not, the same as week 11th)
8. Four-foot Kneeling: four-foot dy-
7. Lying: four-foot isometric extension with elastic
namic extension with elastic belt belt
8. Four-foot kneeling: four-foot isometric extension
Int. J. Environ. Res. Public Health 2022, 19, 11073 with elastic belt on unstable support 8 of 14
ling Dynamic stretching, including upper and lower limbs, waist, back, and abdomen stretching and pelvic
wn floor muscle relaxation with mini foam axis.
Table 2. Data collection and follow-up instruments.
Table 2. Data collection and follow-up instruments.
EG CG
EG EGCG CGEG EGCG CGEG CG
Baseline screen, BaselineInformed screen, consent,
Informed Randomization
consent,EG Randomization
EG EG CGCG EG CG EG CG EG EG EGEG
CG CG CG CGCG EG EG CG EGCG CG
visitsEG
CG CG EG EG EGCG EG The Third CG
EG EG EG CG CG EG CG CG EG CG EGEG CG CG EG CG EGEG CG CG EG CG EGEG CG CGCG
Baseline
Baseline screen, screen,The
Informed
Baseline follow-up
Informed
screen,
consent, Informed The visits
consent,
Randomization follow-up
Randomization
consent, Randomization The First The First The Second The Second The Third
Baseline
eline screen, Baseline
Informed screen,
screen, Informed
Baseline
consent, Informed
screen,
consent, Informed
Baseline
Randomizationconsent,
Randomizationscreen,
consent, Informed
Baseline
Randomization screen,
EG consent, Informed
Baseline
Randomization
CG screen,
EG consent,EG Informed
Baseline
Randomization
CG CG screen,
EG consent,EGInformed
EGRandomization
CG CG EG consent,
CG EGEGRandomization
CG CG EG CG EGEG CG CG EG CG EGEG CG CGCG
Demographic
The follow-up The follow-up
visitsDemographic
data
The follow-up collection
visits visits data collection ◯
The First The First ◯
TheThe ◯FirstSecond ◯
The Second The The Second ThirdThe Third The Third
Baseline screen,The Randomization
follow-up
Informed
Baseline screen,
consent,visits
The follow-up
Informed
Baseline
Randomizationscreen, visits
consent, The follow-up
Informed
Baseline
Randomization Thevisits
screen,
EG consent, The
First follow-up
Informed
Baseline
Randomization
CG Thevisits
screen,
EG consent, The
EGThe
First Second
follow-up
Informed
Baseline
Randomization
CG CG Thevisits
screen,
EG consent, The
EG The
First The
Second
Informed
EG follow-up
Third
Randomization
CG CG EG Thevisits
consent,
CG EGThe
First
EG The
Second Third
Randomization
CG CG EG TheEG
CG The
First
EG The
Second
CG Third
CG EG CGTheEGThe
First
EGThe
Second
CGThird
CGCG
The Demographic
follow-up
Demographic visits
Demographic
dataDemographic
collection
The MOS data collection
data
Thecollection
MOS ◯ The First ◯
●◯ ◯ ◯ ●● The ◯ ●Second ● ● ● ● The ● Third ● ● ●
Baseline screen, The
The follow-up
follow-up
Informed
Baseline data
screen,
consent, visits
Demographic
collection
visits
The follow-up
Informed
Baseline
Randomizationdata Demographic
screen, collection
visits
Informed
Baseline
Randomization ◯
data The
screen,
EG The
Demographic
consent,visits
The
First First
collection
Informed
Baseline◯ EG
follow-up
Randomization
CG ◯
data Demographic
screen,
consent,collection
Thevisits
The
EGThe
First
Informed
Baseline ◯ CG
Second
follow-up
Randomization
CG ◯
data
screen,
EG The
Demographic
The
consent,EG Second
collection
visits
The
The
First The
Informed
EG ◯ Third
Second
follow-up
Randomization
CG CG ◯
data
EG consent,
CG collection
Thevisits
EGThe
First
EGThe ◯ Third
Second
Randomization
CG CG ◯
EG The
CG The
EGThe
First
EGThird
The ◯ Third
Second
CG CG ◯
EG CGTheEGThe
First
EGThe ◯ Third
Second
CG CGCG
Demographic data The MOS The MOS MOS stage #◯
The POP-Q ● ● ●◯ ● ●●● ◯● ◯ ● ● ●● ● ● ● ◯● ●
Baseline Demographic
Demographic
screen, The Thecollection
follow-up
Informed
Baseline MOSdata
data
screen,
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floor professionals viaPFIQ-7: vaginal palpation. ◎: Data would be c
pregnancy, and fetal weight, would be collected at the enrollment visit of the study; while
Floor Impact Questionnaire-7; FSFI-6:the Thefollowing
6-item Female questionnaires would be filled by all participants Physi-
Sexual
experienced Function
General Index;
specialists asIPAQ-SF;
the examiners. International
◯: data would
at be collected by requesting all partic
baseline and at all
cal Activity Questionnairefollow-up Score-Short answers through
Form；RPE: Ratings of Perceived Exertion scanning a QR code. ✷: Recording by all the participants in EG only per their traini
visits: RPE score given by themselves. : Optional items
(1) The International Physical Activity Questionnaire Score-Short Abbreviations: Form (IPAQ-SF), which
3. Data Collection and Management
were recommended as a cost-effective method to assess physical by
MOS: The modified Oxford Scale [3], which needs to be performed insertingby
activity two fingers into th
nine
Demographic data, including the age,
approximately height, 4 cm weight,
to
questions recording the activity of four levels of intensities in short forms: vigorous-feel the body FPM mass
contraction index and (BMI),
give prena-
scale ranging from 0 (no contraction) to
tal maximum weight, physical contraction).;
activity during POP-Qpre-pregnancy
[5]: pelvic organ prolapse and quantitation; PFDI-20:
pregnancy, and The Pelvic Floor Distress I
intensity, moderate-intensity, walking, and sitting [31];
Questionnaire-20; PFIQ-7: Pelvic Floor Impact Questionnaire-7; FSFI-6: The 6-item Female Sexual Fu
(2) The Pelvic Floor IPAQ-SF; DistressInternational Inventory PhysicalQuestionnaire-20
Activity Questionnaire (PFDI-20)
Score-Shortand Form；RPE: Pelvic Ratings Floor of Perceiv
Impact Questionnaire-7 (PFIQ-7), which were designed to comprehensively evaluate
1 1 to what extent the lower urinary tract, lower gastrointestinal tract, and pelvic organ
1 1 1
1 1 1 prolapse1symptoms affect1 the quality
1 of life of women who suffer from PFD [32];
1 1 (3)
1 The Female1 Sexual Function
1 Index (FSFI-6)
1 [33], a common tool that has been validated
1 1 1 for clinical use for evaluating female sexual function in six terms [34,35];
1 1 1
1 1 1
(4) 1
The Pittsburgh 1
Sleep Quality 1
Index (PSQI), which was developed in 1989 and accepted
1 1 1 1 1 1 1 quality [36].
as the most common measure of sleep
1 1 1 1 1 1
Baseline demographic data, IPAQ-SF, PFDI-20, PFIQ-7, FSFI-6, and PSQI were inte-
grated into a WeChat mini program and can be filled by the Participants themselves by
scanning a QR code on WeChat, a social App that is commonly used by the public in China.
The body mass index (BMI) among the demographic data and all the scores or grades for
all the questionnaires can be automatically come out by the configured formulas in the
WeChat mini program.
Following the questionnaires in each of the visits would be the physical examination
including PFM strength evaluation by Modified Oxford Grading (MOS) [3], pelvic organ
prolapse quantitation (POP-Q) stage [5], vaginal relaxtity, symptomatic SUI detection and
grading, pelvic floor surface electromyography (sEMG) based on Glazer protocol [37],
pelvic floor ultrasound examination, quantitative measurement of pelvic sagittal rotation
degree by X-ray, and evaluation of the overall body composition and strength.
Pelvic floor surface electromyography (sEMG) would be tested based on Glazer proto-
col. The participants would be taught to contract the pelvic floor muscle correctly and will
have one practice before testing.
SUI is defined by SUI symptoms or a positive result of the cough stress test. Before the
cough stress test, participants are suggested to keep fully bladder. Positive result of the test
is defined as involuntarily urinary leakage when asked to cough in the lithotomy position.
Pelvic floor ultrasound indicators, which include LAM thickness, diameter of the
levator hiatus, and levator hiatus area, were measured using the proprietary software 4D
View via transperineal ultrasound(GE Kretz Medizintechnik), a reproducible and reliable
measurement of vaginal support [38].
The quantitative measurement of pelvic sagittal rotation degree on Spine X-ray
(Definium7000, General Electric Company, Boston, MD, USA) was analyzed which in-
cludes 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.
The change of the overall body composition would be analyzed through body compo-
sition analyzers (Inbody 770), and overall strength which would be measured through hand
grip strength test and trunk endurance test. Body composition analyzers would analyze
data regarding waist hip ratio, basal metabolic rate, body fat rate, etc. Hand grip strength
would be measured by JAMAR Plus+ grip gauge. The measurement accuracy is 0.1 kg.
The participants should not have visible hand defects. The grip gauge should be adjusted
before measurement. When the participants hold 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. The left and right hand are measured alternately three times. Trunk endurance
would be tested using the Plank test, Side bend test, and Biering–Sorensen Test [39]. All the
participants were encouraged to keep the positions as long as possible. Time as recorded in
seconds with a maximal length of 90 s.
4. Outcomes of the Study

The primary outcome will be the comparison of participants’ pelvic floor muscle
strengths using MOS scale at the enrollment baseline and post intervention. The secondary
outcomes will be: (1) the occurrence of SUI, (2) the change of the Pelvic floor ultrasound
indicators, (3) change of the Pelvic Organ Prolapse Quantitation measured by callipers,
(4) change of the pelvic sagittal rotation degree, and (5) the change of the overall body
composition and strength. The list of data collection instruments and time of data collection
is presented in Tables 2 and 3.
Table 3. Outline of Soring for general pelvic floor function.
Testing Items Indicators Compute Value Score Value

Stage 0 0
Stage I 1
POP-Q Stage II 2
Stage III 3
Stage IV 4
Yes 1
Cough stress test
No 0
≥4 fingers 4
>3 fingers, and <4 fingers 3
Vaginal relaxation
=3 fingers 2
>2 fingers, and <3 fingers 1
≤2 fingers 0
Pelvic floor <20 cm2 Hg 1

electrophysiological test [40] ≥20 cm2 Hg 0
* Total Score 1
PFDI-20 - Comprehensive score
PFIQ-7 - Comprehensive score
FSFI-6 - Comprehensive score
* Total Score 2
* The total score 1 means the sum of all above score values which represents objective indicators for pelvic floor
function. The lower the total score, the better the pelvic floor function; the total score 2 means the sum of the
above three comprehensive score which represents women’s subjective evaluation by themselves for pelvic floor.
The other secondary outcome measures involved in the Table 2 will be calculated and
discussed separately.
4.1. Sample Analysis

Sample size was calculated according to the improvement rate of MOS grade after
12-week training using PASS 2019 software. According to the preliminary experiment,
the improvement rate of MOS in the CG was 20% and that of women in EG was 60% at
6 months postpartum. Group sample sizes of 106 in each group achieve 90.248% power
to detect a difference between the group proportions of 0.4. The CG proportion is 0.2.
The EG proportion is assumed to be 0.4 under the null hypothesis and 0.6 under the
alternative hypothesis. The test statistic used is the one-sided Z test (unpooled). However,
in considering 20% of the possible dropout, a total of 260 women will be randomized.
4.2. Statistical Analysis

Data will be analyzed using SPSS version 26.0 (SPSS, Inc., Chicago, IL, USA) and
the statistically significant difference will be identified if p < 0.05. Descriptive statistics
including numbers and proportions, means and standard deviations, or medians (P25, P75)
will be used. Group differences in the primary and secondary outcomes will mainly use
chi-square and student’s t tests. For primary outcome, we will count the rate of pelvic
muscle strength reaching grade 4 at 6 months postpartum between EG and CG by chi-
square test or Fisher’s exact test as appropriate. Analysis of the primary and secondary
outcomes will be based on an intention-to-treat basis in consideration of the drop-offs from
the follow-ups and be conducted by the statistician at Peking University Clinical Research
Institute. For comparison between groups of quantitative data, the analysis of variance
or Wilcoxon rank sum test will be used according to the data distribution; chi square test
or exact probability method is used for counting data (if chi square test is not applicable),
Wilcoxon rank sum test or CMH test is used for grade data, and logistic regression analysis
is used for correlation analysis. Repeated ANOVA will be used to assess within-patient
correlation. and multivariable linear regression models if potential confounders were
imbalanced.
5. Discussion
Pelvic floor rehabilitation is becoming more and more important due to the rapid de-
velopment of rehabilitation medicine and the improvement of the life quality of demanded
by women. PFMT is one of the widely adopted exercise therapies in the clinic for female
pelvic floor rehabilitation.
Although medical societies realize that rehabilitative exercises to be the currently
demonstrated effective way to improve PFM, consensus on the standard for PFMT is still
lack. Many issues are remaining; questions, such as “what is the right to exercise correctly?”
and “what is the proper frequency and duration for PFM training?”, and reports on the
efficacy of PFMT are much confusing. Due to the positional particularity and abstractness
of pelvic floor muscles, it is difficult for a non-medical backgrounded woman to exercise
pelvic floor muscle fiber I and fiber II directly, accurately, and/or effectively. PFMT has not
been skilled for public populization, although many investigators have efforted exploring
more convenient and effective pelvic floor rehabilitation methods.
In referring to comprehensive literature related to our previous research [20], we
developed 12-week PEFLOW, with emphases on training of the entire muscle system.
PEFLOW is composed of 10 sections as shown in Table 1. The warm-up section
was setup to have the participants percept the pelvic floor contractions in different body
positions via self-feeling to the pelvic floor movements. In this section, participants are
instructed to practice quick contraction (1”) and relaxation (2”) for perception of type II
muscle fiber (fast-twist fiber) and hold-on contraction (8-10”) and relaxation (8-10”) for
perception of type I muscle fibers (slow-twist fiber). The training of multiple repetitions for
fast-twist fibers is also a way of targeting slow-twist fiber [41]. Section 1 was integrated
in the program to train the pelvic contractions corelating to the movements of standing,
heel lifting, single feet standing, and walking. According to the literature, feet play roles
in control and adjustment of postures, and exercises corelated with the movement of feet
can improve body balance and simulate feedback perception [42]. Section 2 was setup to
improve the flexibility and mobility of the lumbar vertebrae and pelvic, so as to make them
adapt the changes in woman’s body postures that is the unavoidable outcome of pregnancy
and delivery due to the changes in lumbar vertebrae bulge, pelvic width and tilt, and
the relevant muscle tension [43]. With Section 3, we tend to train the movements of PFM
with correlating to breaths. It was programed based on a rational from multiple studies
that exhaling maximizes PFM tension and strength [14,44]. Sections 4–8 were programed
to train joint contractions of the core muscles, surrounding muscles and PFMs as what
more and more scientific evidence demonstrated that PFM contraction can be optimized by
joint contractions of the core muscles such as abdominal, lumbar dorsal, and diaphragm
muscles [40], and surrounding muscles such as hip abductors [45,46].
Optimal and long-term therapeutic effects are anticipated. We made PEFLOW be
performed at home due to the meeting restrictions in COVID-19 pandemic. However, we
anticipate that home exercise with the facilitation of online guidance and encouragement
will increase the participation rate and the concordance of the women in taking correct
exercise. The requirement for participants to report the RPE score after each training session
is not only an encouragement to the participants, but a guarantee of the appropriate training
intensity being kept training effectively and safely [47].
The possible limitation of this trial might be that we lack more precise measurements
for physical activity level, such as wrist or waist accelerometers to monitor heart rate during
daily physical activities and trainings.
6. Conclusions
In conclusion, this study is expects that the 12-week online PEFLOW is a cost-effective
training for the recovery of Pelvic floor muscle function, which is suitable for future clinic
trails and also for clinical promotions.
Author Contributions: X.S. and W.J. are responsible for study design, conceptualization, and super-
vision. H.Z. is responsible for data management, writing articles, PEFLOW designs, and instructions
for exercises. H.Z., D.Z., L.G. and B.X., are responsible for writing—review and editing. H.L. is re-
sponsible for software and methodology. Y.D. is responsible for data collection and exercises assistant.
X.S. is responsible for funding acquisition. All authors have read and agreed to the published version
of the manuscript.
Funding: This research was supported by the National Key Technology R&D Program of China (number:
2018YFC2002204) and the Chinese Association of Plastics and Aesthetics (number: 2020-Z-27).
Institutional Review Board Statement: This study protocol has been approved by the Ethics Com-
mittee of Peking University People’s Hospital (number: 2021PHB254-001).
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Data Availability Statement: Not applicable.
Acknowledgments: We thank all the participants in the study, all investigators in the project, and all
clinical examiners from Peking University People’s Hospital for their contributions.
Conflicts of Interest: The authors declare no conflict of interest.
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International Journal of

2.2. Inclusion Criteria

2.3. Exclusion Criteria

2.4. Site Investigators and Roles

2.5. Randomization and Allocation Concealment

2.6. Assessment Schedule

Table 1. The 12-week Pelvic Floor Workout and the sectioning.

Week 8-Scetion Program Week 8-Scetion Program

Week 8-Scetion Program Week 8-Scetion Program

4. Outcomes of the Study

Table 3. Outline of Soring for general pelvic floor function.

Testing Items Indicators Compute Value Score Value

Pelvic floor <20 cm2 Hg 1

4.1. Sample Analysis

4.2. Statistical Analysis

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