Pelvic Floor Muscle WeaknessNCT05218239
Effect of PEFLOW on PFM Function Recovery of Postpartum Women
A study testing Active Comparator: Routine education group and Experimental: Global training group in people with Pelvic Floor Muscle Weakness and Rehabilitation, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Muscle Weakness, Rehabilitation
- What is being tested?
- Active Comparator: Routine education group and Experimental: Global training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiuli Sun, professor, 010-88324354, sunxiuli918@126.com
Hongmei ZHU, doctor, 010-88324354, 1209304228@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Pelvic Floor Muscle Weakness, Rehabilitation
- Being tested
- Active Comparator: Routine education group, Experimental: Global training group
- Keywords
- postpartum, global training, rehabilitation, pelvic floor muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: Routine education groupBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine education group | Active comparator | Routine education, including postpartum lifestyle, Kegel exercise and Knack method. Receives: Behavioral: Active Comparator: Routine education group |
| Global training group | Experimental | Global training was added on the basis of routine education. Receives: Behavioral: Active Comparator: Routine education group; Behavioral: Experimental: Global training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; 1 year postpartum
Secondary outcomes (11)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start2 Nov 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Sun Xiuli, Peking University People's Hospital
- Investigators
- Xiuli Sun, PHD, Study chair, Study Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218239
- Sponsor's protocol ID
- PKUPH6
- Status last verified
- Jul 2022
- First submitted
- 1 Dec 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: (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.
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.
PubMed 36078788
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Workout on Pelvic Floor Muscle Function Recovery of Postpartum Women
- ClinicalTrials.gov ID
- NCT05218239
- Acronym / sponsor ID
- PKUPH6
- Conditions
- Pelvic Floor Muscle Weakness, Rehabilitation
- Keywords
- postpartum, global training, rehabilitation, pelvic floor muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine education group | Active comparator | Behavioral: Active Comparator: Routine education groupRoutine education, including postpartum lifestyle, Kegel exercise and Knack method. |
| Global training group | Experimental | Behavioral: Active Comparator: Routine education group, Behavioral: Experimental: Global training groupGlobal training was added on the basis of routine education. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator: Routine education groupBehavior 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. | Behavioural | Global training group, Routine education group |
| Experimental: Global training groupGlobal 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. | Behavioural | Global training group |
Primary outcome
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.
11 secondary outcomes
The occurrence of SUI
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic floor ultrasound indicators
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic Organ Prolapse Quantitation
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Physical activity levels
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from pelvic sagittal rotation degree
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from body composition
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from body strength
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from Pelvic Floor Distress Inventory（PFDI-20）Questionnaire Score
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from PFIQ-7 Questionnaire Score
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from FSFI-6 Questionnaire Score
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Change from the Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline; After 12 week training or 6th month postpartum；1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Derived from this study: PubMed 36078788Zhu 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.
- Individual participant dataSharing planned: Yes. (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.
Related trials for Pelvic Floor Muscle Weakness
Recruiting
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness
Active, not recruiting
Effects of Kegel Ball and Pelvic Floor Exercises on Sexual Function, Unrınary Incontinence and Quality of Life in Women
Urinary Dysfunction, Vaginal Prolapse
Enrolling by invitationObservational study
Digital Care Programs for Female Pelvic Health
Pelvic Floor Disorders, Pelvic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuli Sun, PHD study chair
Study Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator: Routine education group and Experimental: Global training group in people with Pelvic Floor Muscle Weakness and Rehabilitation, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Sun, PHD (010-88324354, sunxiuli03351@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.