Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411041
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga
Sponsor:
Yuan-Mei Liao RN PhD
Organization:
National Yang Ming Chiao Tung University
Study Overview
Official Title:
Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga on Relieving Genitourinary Symptoms and Improving Sexual Function and Quality of Life in Asian Women With Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 symptoms 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 daysweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None