跳至主要内容
临床试验/NCT06406322
NCT06406322尚未招募不适用

Effects of Aerobic Exercise Training in Addition to Pelvic Floor Muscle Training in Gynecological Cancer Survivors With Pelvic Floor Dysfunction

Atılım University0 个研究点目标入组 40 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Pelvic Floor Symptoms

研究概览

简要总结

The incidence of gynecological cancer and the related death rates in the world are increasing every year. Unfortunately, pelvic floor disorders (PFDs) such as pelvic pain, dyspareunia, vaginal stenosis, and urinary incontinence can result from specific cancer treatments.

Our aim in our study is to examine the effects of aerobic exercise training in addition to pelvic floor muscle training on pelvic floor dysfunction symptoms, pelvic floor muscle strength and endurance, quality of life, functional capacity and fatigue in women surviving gynecological cancer with pelvic floor dysfunction.

Patients diagnosed with gynecological cancer and undergoing treatment will be invited to our research. Patients who meet the inclusion criteria and agree to participate will be divided into two groups as Pelvic Floor Muscle Training (PFMT) and PFMT+Aerobic Exercise by block randomization method.

For evaluation,We will use the Pelvic Floor Distress Inventory (PTDE-20), Pelvic Floor Impact Scale with digital palpation, EORTC QLQ-C30, 6 Minute Walk Test and Piper Fatigue Scale.

详细描述

Pelvic floor muscle training (PFMT) is recommended as a first-line conservative treatment in women with PFD. The purpose of these exercises is to maintain and improve pelvic floor muscle strength, endurance, flexibility, and coordination. In a study examining the effects of a home-based rehabilitation program on UI in endometrial cancer survivors, 12 weeks of PFMT, bladder, and life changes education were provided. As a result of the study, it was reported that the home program could be effective in reducing UI symptoms.

Aerobic exercise training is a method that can ameliorate the loss of skeletal muscle mass and function. In studies evaluating the relationship between physical activity and UI, there are studies showing that walking is positively associated with the reduction of UI symptoms. However, when the literature was examined, no study was found evaluating the effect of aerobic exercise training on PFD in individuals with gynecological cancer.

There are studies in the literature examining the effect of PFMT on different types of gynecological cancer. Studies have shown that different exercise programs are effective in reducing symptoms of pelvic floor dysfunctions seen after treatment in gynecological cancer patients and increasing pelvic floor muscle strength, thus increasing the quality of life. When the studies were examined, no study was found examining the effects of aerobic exercise training in addition to pelvic floor muscle training on PFD symptoms, pelvic floor muscle functions, quality of life, functional capacity, and fatigue in women surviving gynecological cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Volunteers who have at least one symptom of PFD (UI, anal incontinence, pelvic organ prolapse) due to gynecological cancer treatment,
  • At least 12 months have passed since completing surgery, chemotherapy, or radiotherapy treatments,
  • Being over 18 years old,
  • Karnofsky performance scale being greater than 90,
  • Being literate.

排除标准

  • Having symptoms of pelvic floor dysfunction before cancer diagnosis,
  • Diagnosed with metastatic cancer,
  • Having a pelvic infection,
  • Having any orthopedic, neurological, or cardiopulmonary disease that would prevent them from exercising,
  • Having morbid obesity,
  • Those who have communication and cooperation problems.

结局指标

主要结局

Pelvic Floor Symptoms

时间窗: change from baseline at 8 weeks

The Pelvic Floor Distress Inventory (PFDI-20) will be used to measure the severity of patients' pelvic floor symptoms.The PFDI-20 scale consists of 20 questions in total and three subscales: Urinary Distress Inventory (UDI-6), Pelvic Organ Prolapse Distress Inventory (POPDI-6), and Colorectal-Anal Distress Inventory (CRADI-8) .A total of 0-300 points can be obtained in the three sections. As the score approaches 300, the degree of complaint increases.

次要结局

  • Functional capacity(change from baseline at 8 weeks)
  • Pelvic floor muscle strength(change from baseline at 8 weeks)
  • Quality of life due to pelvic floor dysfunctions(change from baseline at 8 weeks)
  • Cancer-related quality of life(change from baseline at 8 weeks)
  • Fatigue(change from baseline at 8 weeks)

研究者

发起方
Atılım University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma Busra Benguboz

Lecturer

Atılım University

相似试验