Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer

NCT ID: NCT06406322

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-06-01

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.

Conditions

Gynecologic Cancer; Pelvic Floor Disorders; Aerobic Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pelvic Floor Muscle Training (PFMT) Group

Training will be planned for patients, including strengthening and endurance exercises,

Group Type: ACTIVE_COMPARATOR

PFMT

Intervention Type: OTHER

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.).

PFMT + Aerobic Exercise Group

Both groups will be given PFMT, and the Grup B group will be given aerobic exercise training in addition to PFMT.

Group Type: EXPERIMENTAL

PFMT

Intervention Type: OTHER

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.).

Aerobic Exercise

Intervention Type: OTHER

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.

Interventions

PFMT

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.).

Intervention Type: OTHER

Aerobic Exercise

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atılım University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Busra Benguboz

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seyda TOPRAK CELENAY, Assoc. Prof.

Role: STUDY_CHAIR

Ankara Yildirim Beyazıt University

Central Contacts

Fatma Büşra BENGÜBOZ

Role: CONTACT

busrabenguboz@gmail.com

+905074988395

Other Identifiers

AU-BENGUBOZ-002

Identifier Type: -

Identifier Source: org_study_id