Effect of PEFLOW on PFM Function Recovery of Postpartum Women

NCT ID: NCT05218239

Last Updated: 2022-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2023-06-30

Brief 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. 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.

Conditions

Pelvic Floor Muscle Weakness; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine education group

Routine education, including postpartum lifestyle, Kegel exercise and Knack method.

Group Type: ACTIVE_COMPARATOR

Active Comparator: Routine education group

Intervention Type: BEHAVIORAL

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.

Global training group

Global training was added on the basis of routine education.

Group Type: EXPERIMENTAL

Active Comparator: Routine education group

Intervention Type: BEHAVIORAL

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 group

Intervention Type: BEHAVIORAL

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.

Interventions

Active Comparator: Routine education group

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.

Intervention Type: BEHAVIORAL

Experimental: Global training group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sun Xiuli

professor; chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiuli Sun, PHD

Role: STUDY_CHAIR

Study Chair

Locations

The Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuli Sun, PHD

Role: CONTACT

sunxiuli03351@126.com

010-88324354

Facility Contacts

Xiuli Sun, professor

Role: primary

sunxiuli918@126.com

010-88324354

Hongmei ZHU, doctor

Role: backup

1209304228@qq.com

010-88324354

References

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.

Reference Type: DERIVED

PMID: 36078788 (View on PubMed)

Other Identifiers

PKUPH6

Identifier Type: -

Identifier Source: org_study_id