Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer

Trial Title: Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer

NCT ID: NCT06406322

Condition: Gynecologic Cancer
Pelvic Floor Disorders
Aerobic Exercise

Conditions: Official terms:
Pelvic Floor Disorders

Conditions: Keywords:
Pelvic Floor Dysfunction
Gynecologic Cancer
Physiotherapy

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: PFMT
Description: Pelvic floor muscle training will be given to patients with strengthening and endurance exercises for 8 weeks. PFMT will be applied at a patient-specific progression for 8 weeks.Exercises will be given in different positions (supine, sitting, etc.).
Arm group label: PFMT + Aerobic Exercise Group
Arm group label: Pelvic Floor Muscle Training (PFMT) Group

Intervention type: Other
Intervention name: Aerobic Exercise
Description: Aerobic exercise will be applied as a progressive program in the form of a walking program, at least 4 days a week for 8 weeks. There will be 5-minute warm-up and cool-down periods (walking at a light pace) before and after exercise.
Arm group label: PFMT + Aerobic Exercise Group

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.

Criteria for 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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: June 1, 2024

Completion date: June 1, 2026

Lead sponsor:
Agency: Atılım University
Agency class: Other

Source: Atılım University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06406322