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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Vulvovaginal Symptoms — Baseline
  The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
• Vulvovaginal Symptoms — 4 weeks after baseline
  The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
• Vulvovaginal Symptoms — 8 weeks after baseline
  The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
• Vulvovaginal Symptoms — 12 weeks after baseline
  The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.
• Vulvovaginal Symptoms — 24 weeks after baseline
  The 21-item Chinese version of the Vulvovaginal Symptoms Questionnaire (C-VSQ) comprises four subscales to assess vulvovaginal symptoms experienced during the past week (Items 1-7), and symptom-related influences (Emotions Items 8-11; Life-impact Items 12-15, and Sexual-impact Items 16, 18-21). The response options for all items are "Yes" (1 point) and "No" (0 point). Subscale scores are the sum of the scores for the items included in that subscale. The C-VSQ total score is the sum of three subscale scores (0-15 points) or four subscale scores (0-20 points for sexually active women). A higher C-VSQ total score indicates experiencing greater severity of vulvovaginal symptoms and symptom-related influences.

Trial sites (1)

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