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

NCT05318768 | Completed DMC

• 1 other identifier: PKUPH7
• Study Type: observational
• Target: 929
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders; Pelvic Floor Muscle Weakness

Keywords

women; physical activity; overall muscle strength; hand grip strength; pelvic floor muscle strength

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Peking University: collaborator

Study Sites (1)

Peking University Peoples Hospital

Beijing, Beijing Municipality, 10000, China

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Behavior

Study Officials

• Xiuli Sun, PHD

  Study Chair

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 8, 2022
• Study Start: October 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: April 30, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2years
• Access Criteria: contact the researchers

Locations

CN (1)