Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.

Pelvic Floor Disorders Clinical Trial

Official title:

Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05318768
• Other study ID #: PKUPH7
• Status: Completed
• Start date: October 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2023
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 929
• Est. completion date: April 30, 2022
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Gynecological outpatient clinic patients
• In good condition and able to actively cooperate
• Agree to conduct the study.
• Age range: 18 to 80 years old

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Muscle Weakness
• Pelvic Floor Disorders
• Pelvic Floor Muscle Weakness

Locations

Country	Name	City	State
China	Peking University Peoples Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion,an average of one day
Primary	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.	through study completion,an average of one day
Primary	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.	through study completion, an average of the past one week
Primary	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.	through study completion, an average of the past 3 months
Primary	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.	through study completion, an average of the past four weeks