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Trial Title:
Effects of a Combined Program of Pelvic Floor Muscle Training and Yoga
NCT ID:
NCT06411041
Condition:
Genitourinary Symptoms
Sexual Function
Quality of Life
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The experimental group will receive regular care and a 12-week program of pelvic floor
muscle training (PFMT) and yoga. The control group will receive regular care.
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
The outcome assessor will not be informed about the group of the participants
Intervention:
Intervention type:
Behavioral
Intervention name:
Pelvic Floor Muscle Training (PFMT) and yoga
Description:
The experimental group participants will be instructed to perform the practice session
four days a week. The four days per week practice times (PFMT 15 minutes/day; yoga 40
minutes/day.) will result in weekly practice times for pelvic floor muscle training
(PFMT) of 60 minutes and for yoga of ≥150 minutes.
Arm group label:
Intervention group
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 20-60 years
- Women with a confirmed diagnosis of breast cancer (Stages I-III) for ≥3 months
- Women who experience ≥1 genitourinary symptom(s)
Exclusion Criteria:
- Women with other types of cancer diagnoses (e.g., endometrial cancer and ovarian
cancer)
- Women with inadequately managed chronic conditions (e.g., an individual with
diabetes having HbA1c level >7%)
Gender:
Female
Gender based:
Yes
Gender description:
Women who aged 20-60 years, with a confirmed diagnosis of breast cancer (Stages I-III)
for ≥3 months, and experience ≥1 genitourinary symptom(s)
Minimum age:
20 Years
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
May 30, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Yuan-Mei Liao, RN, PhD
Agency class:
Other
Source:
National Yang Ming Chiao Tung University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06411041
