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Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer

A

Atılım University

Status

Not yet enrolling

Conditions

Aerobic Exercise
Pelvic Floor Disorders
Gynecologic Cancer

Treatments

Other: Aerobic Exercise
Other: PFMT

Study type

Interventional

Funder types

Other

Identifiers

NCT06406322
AU-BENGUBOZ-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Pelvic Floor Muscle Training (PFMT) Group
Active Comparator group
Description:
Training will be planned for patients, including strengthening and endurance exercises,
Treatment:
Other: PFMT
PFMT + Aerobic Exercise Group
Experimental group
Description:
Both groups will be given PFMT, and the Grup B group will be given aerobic exercise training in addition to PFMT.
Treatment:
Other: PFMT
Other: Aerobic Exercise

Trial contacts and locations

0

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Central trial contact

Fatma Büşra BENGÜBOZ

Data sourced from clinicaltrials.gov

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