Clinical trial NCT05318768: Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.
Official title: Association Between Physical Activity Level ，Overall Muscle Strength and Pelvic Floor Muscle Function in Women.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Disorders
Pelvic Floor Muscle Weakness
Keywords: women
physical activity
overall muscle strength
hand grip strength
pelvic floor muscle strength
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2022-04-08
Enrollment: 929
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pelvic floor muscle strength grading
timeFrame: through study completion，an average of one day
measure: Overall body strength measured by hand grip strength
timeFrame: through study completion，an average of one day
measure: Physical activity levels
timeFrame: through study completion, an average of the past one week
measure: Pelvic Floor Distress Inventory#PFDI-20#Questionnaire Score
timeFrame: through study completion， an average of the past 3 months
measure: FSFI-6 Questionnaire Score
timeFrame: through study completion， an average of the past four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Peoples Hospital
state: Beijing
Study officials:
affiliation: Study Chair
name: Xiuli Sun, PHD
role: STUDY_CHAIR
References: