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

NCT06411041 | Enrolling By Invitation

• 1 other identifier: 24MMHIS120e
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Genitourinary Symptoms; Sexual Function; Quality of Life

Outcome Measures

Primary Outcomes (5)

• Vulvovaginal Symptoms

  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.

  Baseline

• Vulvovaginal Symptoms

  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.

  4 weeks after baseline

• Vulvovaginal Symptoms

  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.

  8 weeks after baseline

• Vulvovaginal Symptoms

  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.

  12 weeks after baseline

• Vulvovaginal Symptoms

  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.

  24 weeks after baseline

Secondary Outcomes (5)

• Urinary symptoms

  Baseline

• Urinary symptoms

  4 weeks after baseline

• Urinary symptoms

  8 weeks after baseline

• Urinary symptoms

  12 weeks after baseline

• Urinary symptoms

  24 weeks after baseline

Other Outcomes (10)

• Sexual function

  Baseline

• Sexual function

  4 weeks after baseline

• Sexual function

  8 weeks after baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Pelvic Floor Muscle Training (PFMT) and yoga

Control group

NO INTERVENTION

The control group will receive regular care

Interventions

Pelvic Floor Muscle Training (PFMT) and yoga 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.

Intervention group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: 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)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Yuan-Mei Liao, PhD

  National Yang Ming Chiao Tung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will not be informed about the group of the participants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: September 25, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Baseline and 4, 8, 12 weeks after baseline
• Access Criteria: Data are available on request due to privacy and ethical restrictions.

Locations

TW (1)