Clinical trial NCT06406322: Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer
Official title: Effects of Aerobic Exercise Training in Addition to Pelvic Floor Muscle Training in Gynecological Cancer Survivors With Pelvic Floor Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Pelvic Floor Disorders
Aerobic Exercise
Keywords: Pelvic Floor Dysfunction
Gynecologic Cancer
Physiotherapy
Lead sponsor: Atılım University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pelvic Floor Symptoms
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: Pelvic floor muscle strength
timeFrame: change from baseline at 8 weeks
measure: Quality of life due to pelvic floor dysfunctions
timeFrame: change from baseline at 8 weeks
measure: Cancer-related quality of life
timeFrame: change from baseline at 8 weeks
measure: Functional capacity
timeFrame: change from baseline at 8 weeks
measure: Fatigue
timeFrame: change from baseline at 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda TOPRAK CELENAY, Assoc. Prof.
role: STUDY_CHAIR
References: