Synergistic Effects of Traditional Chinese Medicine Practices and Pelvic Floor Muscle Training

NCT06877325 | Completed

• 1 other identifier: GCPI2022
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted within a randomized controlled trial framework using a double-blind design. Participants were assigned to one of three intervention groups: the Pelvic Floor Muscle Training group (PFMT), the Pelvic Floor Muscle Training combined with the Qigong group (PFMTQG), and the Qigong Practice group (QG). Randomization was performed using a random number table. Professional trainers implemented the intervention programs. Researchers conducted a 12-week intervention study, with training sessions held thrice weekly. During the trial, participants agreed not to engage in other forms of physical exercise.

Conditions

Maternal Stress

Outcome Measures

Primary Outcomes (2)

• Incontinence Episode Frequency

  Incontinence Episode Frequency (IEF) will be measured using a 72-hour bladder diary maintained by participants. Participants will be provided with a structured bladder diary template, which includes columns for recording each instance of urine leakage, the associated activity (e.g., coughing, sneezing, physical exertion), and the approximate volume of leakage (if subjectively estimable). The frequency of urine leakage episodes will be calculated by averaging the total number of incidents recorded over the three days at each assessment point. The 72-hour urinary incontinence episode values will represent the total number of leakage incidents observed across the three days and will be used to evaluate changes in IEF over time.

  Month 3

• 1-hour Pad Test

  Urine leakage will be objectively quantified using the 1-hour pad test, conducted at the same time points as the bladder diary assessments. Participants will be provided with pre-weighed absorbent pads and instructed to wear them for a continuous 1-hour period. During this time, participants will be asked to drink 500 ml of plain water over 15 minutes and perform normal activities, including simple walking for the next 30 minutes. In the last 15 minutes, participants will be instructed to perform the standard ICS provocation exercises in a private area. If a participant is found to have vaginal bleeding or excessive vaginal discharge, the test will be postponed and rescheduled for a later date. After the 1-hour period, participants will seal the pads in provided plastic bags and return them to the study site. Trained assessors will measure the weight difference between the pre- and post-use pads using a precision digital scale .

  Month 3

Secondary Outcomes (4)

• Pelvic Floor Muscle Assessment

  Month 3

• Incontinence Impact Questionnaire-7

  Month 3

• Urinary Distress Inventory-6

  Month 3

• Psychological Well-being Assessment

  Month 3

Study Arms (3)

Pelvic floor muscle training

EXPERIMENTAL

Behavioral: PFMT

Qigong with pelvic floor muscle training

EXPERIMENTAL

Behavioral: QGPFMT

Qigong

EXPERIMENTAL

Behavioral: Qigong

Interventions

PFMT BEHAVIORAL

The training is divided into three phases. The first phase is the foundation phase (Weeks 1-4), which primarily activates the pelvic floor muscles. Strengthening Phase (Weeks 5-8): Builds muscular endurance and control by increasing contraction duration. Consolidation Phase (Weeks 9-12): Enhances overall stability and strength through functional movements.

Pelvic floor muscle training

QGPFMT BEHAVIORAL

The training is divided into three phases: Foundation Phase (Weeks 1-4): Focuses on breath regulation and activation to promote energy flow and awaken the pelvic floor muscles. Strengthening Phase (Weeks 5-8): Combines core stability training to enhance muscle strength and flexibility. Consolidation Phase (Weeks 9-12): This phase strengthens core control while incorporating standing meditation and breathing exercises to harmonize body and mind, improving overall stability and endurance.

Qigong with pelvic floor muscle training

Qigong BEHAVIORAL

The training is divided into three phases. The first phase (Weeks 1-4) focuses on breathing regulation and relaxation to enhance blood circulation and promote body recovery. Strengthening Phase (Weeks 5-8): Utilizes "Dao Yin" techniques to improve flexibility and stimulate energy flow. Consolidation Phase (Weeks 9-12): Emphasizes overall enhancement and core strengthening and incorporates extended deep breathing meditation to harmonize body and mind.

Qigong

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 20-35 years.
• Within 12 months postpartum.
• Diagnosed with mild to moderate SUI.
• Physically capable of participating in mild to moderate exercise.
• Provided written informed consent.

You may not qualify if:

• Severe pelvic floor dysfunction.
• Systemic health conditions that contraindicate physical activity.
• Pregnant at the time of recruitment or planning pregnancy during the study
• Prior structured training in Qigong or PFMT.
• Ongoing physiotherapy for pelvic floor health.
• Participation in other urinary incontinence research.
• Inability to provide informed consent due to cognitive or language barriers.

Sponsors & Collaborators

• Guangxi College for Preschool Education: lead

Study Sites (1)

Faculty of Sports Science

Nanning, Guangxi, 530022, China

Location

MeSH Terms

Interventions

Qigong

Intervention Hierarchy (Ancestors)

Breathing Exercises; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 14, 2025
• Study Start: October 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 10, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)