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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Genitourinary Symptoms Sexual Function Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessor will not be informed about the group of the participants

Study Groups

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Intervention group

The experimental group will receive regular care and a 12-week program of pelvic floor muscle training (PFMT) and yoga

Group Type EXPERIMENTAL

Pelvic Floor Muscle Training (PFMT) and yoga

Intervention Type BEHAVIORAL

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.

Control group

The control group will receive regular care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pelvic Floor Muscle Training (PFMT) and yoga

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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%)

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No