Pelvic Floor DisordersNCT05318768
Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.
An observational study of Pelvic Floor Disorders and Pelvic Floor Muscle Weakness, run by Peking University People's Hospital at 1 site in China.
Trial summary
In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Disorders, Pelvic Floor Muscle Weakness
- How many people
- 929 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Apr 2022
- Phase
- Observational
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is a cross-sectional observational study, planned to enroll 1143 participants from Gynecology Outpatient Clinic. PASS.15 software was used for sample size calculation. α- error level was set as 0.05, U0.05=1.96. For the main indicators, according to the epidemiological investigation of FEMALE PFD by our previous study, the comprehensive selection of PFD prevalence is 10%, and error δ=4%, calculated n=914, proposed to increase the loss rate by 20%. The sample size was about 1143.
Who may be able to join
- Gynecological outpatient clinic patients
- In good condition and able to actively cooperate
- Agree to conduct the study.
- Age range: 18 to 80 years old
Who cannot join
- Patients who has a history of pelvic surgery or has had pelvic floor functional diseases
- Patients who do not have sex
- Pregnancy
- Patients who have serious medical diseases
- Patients with cardiac dysfunction or wear pacemakers
- Patients with neurological diseases and cognitive impairment who are difficult to cooperate with the study
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Peoples Hospital
Beijing, Beijing Municipality, 10000
About this study
In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating pelvic floor muscle function. Moderate physical activity and increase the overall strength can activate the potential mechanism of pelvic floor muscle contraction at the same time may be a "core muscles" overall effect, that core muscles mainly includes transverse abdominal muscle, pelvic floor muscles and the muscles around the back, these muscles in the body movement to spontaneous collaboration contract pelvic floor muscles, enhancing pelvic floor muscle function, thus reducing the incidence of pelvic floor dysfunction.
Read the detailed description
This study is a cross-sectional observational study, planned to enroll 942 participants from Gynecology Outpatient Clinic. Uniformly trained physicians as investigators to collect indicators from questionnaires and physical examinations.
Questionnaires may contain general information which include the patient's age, height, body weight before pregnancy and childbirth, weight gain during pregnancy, gestational age, pregnancy time, production time, high palace, delivery mode, neonatal birth weight, body length, blood sugar, blood fat, whether or not to use during pregnancy, childbirth, labor, perineal laceration, forceps midwifery, episiotomy and epidural data, pelvic floor cognition degree, physical activity levels, pelvic floor dysfunction score, pelvic floor functional impact score and sexual function score (including the prenatal and postnatal participants).
Physical examinations will be performed without the results of the questionnaire, including stress tests, pelvic floor POP-Q staging, pelvic floor muscle strength by palpation, vaginal relaxation degree, grip strength value, rectus abdominis separation, waist circumference, waist-hip ratio, etc.
Through univariate analysis of the general data of the patients, the related factors of female PFD were obtained, and the independent influencing factors of PFD were found by binary Logistic regression analysis (the dependent variable in this study was a dichotomous variable). The ROC curve was used to evaluate the predictive value of patients' overall strength level, physical activity level, body shape and other indicators on PFD outcome.
- Keywords
- women, physical activity, overall muscle strength, hand grip strength, pelvic floor muscle strength
- Medical subject headings
- Pelvic Floor Disorders, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic floor muscle strength grading
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 contraction.
Measured: through study completion，an average of one day
Overall body strength measured by hand grip strength
Grip strength index is used to evaluate adult muscle strength in Chinese National Physical Fitness Standards. Grip strength is an important indicator to evaluate an individual's upper limb strength and can reflect the overall muscle strength level which was used to evaluate the overall strength of participants.
Measured: through study completion，an average of one day
Physical activity levels
International Physical Activity Questionnaire score- short from is used to measure the overall physical activity level. Paticipants volunteered for the study and filled out questionnaires to rate their levels of physical activity over the past week which can represent the overall physical activity level.
Measured: through study completion, an average of the past one week
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: through study completion， an average of the past 3 months
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: through study completion， an average of the past four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start1 Oct 2021
- Primary completion30 Oct 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 929 participants (actual)
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
- NCT05318768
- Sponsor's protocol ID
- PKUPH7
- Status last verified
- Feb 2023
- First submitted
- 23 Mar 2022
- Last updated
- 6 Feb 2023
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.
- ClinicalTrials.gov ID
- NCT05318768
- Acronym / sponsor ID
- PKUPH7
- Keywords
- women, physical activity, overall muscle strength, hand grip strength, pelvic floor muscle strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 929 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 8 Apr 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.
In this study, it is assumed that grip strength is associated with pelvic floor muscle strength. And the outcome of pelvic floor function can be predicted by referring to the status of pelvic floor muscle strength through the value of grip strength, which is labor-saving, time-saving and more convenient for evaluating pelvic floor muscle function. Moderate physical activity and increase the overall strength can activate the potential mechanism of pelvic floor muscle contraction at the same time may be a "core muscles" overall effect, that core muscles mainly includes transverse abdominal muscle, pelvic floor muscles and the muscles around the back, these muscles in the body movement to spontaneous collaboration contract pelvic floor muscles, enhancing pelvic floor muscle function, thus reducing the incidence of pelvic floor dysfunction.
Detailed description
This study is a cross-sectional observational study, planned to enroll 942 participants from Gynecology Outpatient Clinic. Uniformly trained physicians as investigators to collect indicators from questionnaires and physical examinations.
Questionnaires may contain general information which include the patient's age, height, body weight before pregnancy and childbirth, weight gain during pregnancy, gestational age, pregnancy time, production time, high palace, delivery mode, neonatal birth weight, body length, blood sugar, blood fat, whether or not to use during pregnancy, childbirth, labor, perineal laceration, forceps midwifery, episiotomy and epidural data, pelvic floor cognition degree, physical activity levels, pelvic floor dysfunction score, pelvic floor functional impact score and sexual function score (including the prenatal and postnatal participants).
Physical examinations will be performed without the results of the questionnaire, including stress tests, pelvic floor POP-Q staging, pelvic floor muscle strength by palpation, vaginal relaxation degree, grip strength value, rectus abdominis separation, waist circumference, waist-hip ratio, etc.
Through univariate analysis of the general data of the patients, the related factors of female PFD were obtained, and the independent influencing factors of PFD were found by binary Logistic regression analysis (the dependent variable in this study was a dichotomous variable). The ROC curve was used to evaluate the predictive value of patients' overall strength level, physical activity level, body shape and other indicators on PFD outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a cross-sectional observational study, planned to enroll 1143 participants from Gynecology Outpatient Clinic. PASS.15 software was used for sample size calculation. α- error level was set as 0.05, U0.05=1.96. For the main indicators, according to the epidemiological investigation of FEMALE PFD by our previous study, the comprehensive selection of PFD prevalence is 10%, and error δ=4%, calculated n=914, proposed to increase the loss rate by 20%. The sample size was about 1143.
Key inclusion criteria (4 listed)
- Gynecological outpatient clinic patients
- In good condition and able to actively cooperate
- Agree to conduct the study.
- Age range: 18 to 80 years old
Key exclusion criteria (6 listed)
- Patients who has a history of pelvic surgery or has had pelvic floor functional diseases
- Patients who do not have sex
- Pregnancy
- Patients who have serious medical diseases
- Patients with cardiac dysfunction or wear pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic floor muscle strength grading
Time frame: through study completion，an average of one day
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 contraction.
Overall body strength measured by hand grip strength
Time frame: through study completion，an average of one day
Grip strength index is used to evaluate adult muscle strength in Chinese National Physical Fitness Standards. Grip strength is an important indicator to evaluate an individual's upper limb strength and can reflect the overall muscle strength level which was used to evaluate the overall strength of participants.
Physical activity levels
Time frame: through study completion, an average of the past one week
International Physical Activity Questionnaire score- short from is used to measure the overall physical activity level. Paticipants volunteered for the study and filled out questionnaires to rate their levels of physical activity over the past week which can represent the overall physical activity level.
Pelvic Floor Distress Inventory#PFDI-20#Questionnaire Score
Time frame: through study completion， an average of the past 3 months
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.
FSFI-6 Questionnaire Score
Time frame: through study completion， an average of the past four weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- 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.
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Comparing the Effect of Two Types of Pelvic Floor Muscle Stimulation Devices to Improve Symptoms of Urinary Incontinence in Women.
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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?
An observational study of Pelvic Floor Disorders and Pelvic Floor Muscle Weakness, 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 6 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic floor muscle strength grading (time frame: through study completion，an average of one day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2023.