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Набор по приглашению NCT06411041

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

Без фазы С лечением Genitourinary Symptoms Sexual Function Quality of Life

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Pelvic Floor Muscle Training (PFMT) and yoga.
Кому может быть актуально
Состояния в реестре: Genitourinary Symptoms, Sexual Function, Quality of Life. Базовые параметры: 20 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

  • Vulvovaginal Symptoms [Срок оценки: Baseline]
  • Vulvovaginal Symptoms [Срок оценки: 4 weeks after baseline]
  • Vulvovaginal Symptoms [Срок оценки: 8 weeks after baseline]
  • Vulvovaginal Symptoms [Срок оценки: 12 weeks after baseline]
  • Vulvovaginal Symptoms [Срок оценки: 24 weeks after baseline]
Вторичные конечные точки (5)
  • Urinary symptoms [Срок оценки: Baseline]
  • Urinary symptoms [Срок оценки: 4 weeks after baseline]
  • Urinary symptoms [Срок оценки: 8 weeks after baseline]
  • Urinary symptoms [Срок оценки: 12 weeks after baseline]
  • Urinary symptoms [Срок оценки: 24 weeks after baseline]

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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%)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • MacKay Memorial Hospital — Taipei

Идентификаторы

NCT: NCT06411041 · 24MMHIS120e

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗