Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer

NCT06406322 | Not Yet Recruiting

• 1 other identifier: AU-BENGUBOZ-002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gynecologic Cancer; Pelvic Floor Disorders; Aerobic Exercise

Keywords

Pelvic Floor Dysfunction; Gynecologic Cancer; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Pelvic Floor Symptoms

  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.

  change from baseline at 8 weeks

Secondary Outcomes (5)

• 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

• Functional capacity

  change from baseline at 8 weeks

• Fatigue

  change from baseline at 8 weeks

Study Arms (2)

Pelvic Floor Muscle Training (PFMT) Group

ACTIVE COMPARATOR

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

Other: PFMT

PFMT + Aerobic Exercise Group

EXPERIMENTAL

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

Other: PFMT; Other: Aerobic Exercise

Interventions

PFMT 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; Pelvic Floor Muscle Training (PFMT) Group

Aerobic Exercise 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.

PFMT + Aerobic Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atılım University: lead

MeSH Terms

Conditions

Pelvic Floor Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Seyda TOPRAK CELENAY, Assoc. Prof.

  Ankara Yildirim Beyazıt University

  STUDY CHAIR

Central Study Contacts

Fatma Büşra BENGÜBOZ

CONTACT

+905074988395; busrabenguboz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 9, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 9, 2024

Record last verified: 2024-05