Effects of a Combined Program of Pelvic Floor Muscle Training & Yoga

Status Not yet recruiting

Clinical Trial Summary

This study aims to examine the effects of Pelvic Floor Muscle Training (PFMT) combined with yoga on relieving genitourinary symptoms, symptom-related quality of life, and improving sexual function in women with breast cancer. This study is a parallel randomized study with two groups. Women will be assigned to the experimental or control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. The control group will receive regular care. We collect relevant data from both groups at baseline and 4, 8, 12, and 24 weeks after baseline during the study period.

Clinical Trial Description

This study will be conducted with the approval obtained from the Institutional Review Board (IRB) of MacKay Memorial Hospital. This parallel-two-group randomized experimental study including an experimental group and a control group examines the effects of pelvic floor muscle training (PFMT) combined with yoga on genitourinary symptoms, symptom-related quality of life, and sexual function. A sample of women with breast cancer experiencing ≥1 genitourinary symptom(s) will be recruited and assigned to an experimental group or a control group by using the block randomization method. The experimental group will receive regular care and a 12-week program of PFMT and yoga. We will provide the experimental group with 12 days of online group practice sections of PFMT and yoga (weekly 60-minute practice incudes yoga 40 minutes, PFMT 15 minutes, and reflection 5 minutes). We expect them to perform 36 days of home-based practice of PFMT and yoga with 3 days/week of yoga for 40 minutes and PFMT for 15 minutes. The control group will receive regular care and relevant educational materials after data collection. Information will be collected at five time points: baseline and 4, 8, 12, and 24 weeks after baseline. Generalized estimating equation procedures will be used to examine the effects of the intervention. We hypothesized that the experimental group will display more significant improvements in genitourinary symptoms, symptom-related influences, and sexual function than those shown in the control group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06411041
Study type	Interventional
Source	National Yang Ming Chiao Tung University
Contact	Yuan-Mei Liao, PhD
Phone	886-2-28267347
Email	ymliao@nycu.edu.tw
Status	Not yet recruiting
Phase	N/A
Start date	May 30, 2024
Completion date	December 31, 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms