Gynecologic CancerNCT06406322
Pelvic Floor Dysfunction and Aerobic Training in Gynecological Cancer
A study testing PFMT and Aerobic Exercise in people with Gynecologic Cancer and Pelvic Floor Disorders, run by Atılım University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Pelvic Floor Disorders, Aerobic Exercise
- What is being tested?
- PFMT and Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Aerobic Exercise Training in Addition to Pelvic Floor Muscle Training in Gynecological Cancer Survivors With Pelvic Floor Dysfunction
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.
Read more
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.
Read the 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
- Being tested
- PFMT, Aerobic Exercise
- Keywords
- Pelvic Floor Dysfunction, Gynecologic Cancer, Physiotherapy
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMTOther
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 ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) Group | Active comparator | Training will be planned for patients, including strengthening and endurance exercises, Receives: 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. Receives: Other: PFMT; Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at 8 weeks
Secondary outcomes (5)
Pelvic floor muscle strength
Pelvic floor muscle strength will be assessed during digital palpation with the Modified Oxford Scale (MOS) . Scoring according to squeezing intensity is done and noted as follows: 0 = No contraction, 1 = Very weak, 2 = Weak, 3 = Moderate, 4 = Good, and 5 = Strong. During the evaluation by digital palpation, the duration of contraction for muscle endurance will also be recorded.
Measured: change from baseline at 8 weeks
Quality of life due to pelvic floor dysfunctions
The Pelvic Floor Impact Scale-7 will be used to evaluate patients' quality of life due to pelvic floor dysfunctions. The scale is a functional status measure that evaluates the impact of a person's bowel, bladder, and/or pelvic symptoms on different daily living activities, social relationships, or emotions. A scale score between 0 and 100 is obtained for each subscale. A high score indicates poor quality of life.
Measured: change from baseline at 8 weeks
Cancer-related quality of life
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) will be used to evaluate patients' cancer-related quality of life. The scale consists of three subheadings: general well-being, functional area, and symptom control. While high scores for all sections except the symptom score indicate a high quality of life, high scores for the symptom score indicate low quality of life.
Measured: change from baseline at 8 weeks
Functional capacity
To evaluate functional capacity, patients will undergo a 6-minute walk test (6MWT) in accordance with the American Thoracic Society criteria. Individuals will be asked to walk at their maximum speed along a 30-meter corridor. The distance walked by the patient until the time is up or the point they wish to finish the test will be recorded.
Measured: change from baseline at 8 weeks
Fatigue
Functional Assessment in the Treatment of Chronic Diseases - Fatigue Scale will be used to evaluate patients' fatigue.The scores that can be obtained from the scale vary between 0-52. A high total score on the scale indicates that the severity of fatigue is low.
Measured: change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atılım University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Busra Benguboz, Atılım University
- Investigators
- Seyda TOPRAK CELENAY, Assoc. Prof., Study chair, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406322
- Sponsor's protocol ID
- AU-BENGUBOZ-002
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise Training in Addition to Pelvic Floor Muscle Training in Gynecological Cancer Survivors With Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT06406322
- Acronym / sponsor ID
- AU-BENGUBOZ-002
- Conditions
- Gynecologic Cancer, Pelvic Floor Disorders, Aerobic Exercise
- Keywords
- Pelvic Floor Dysfunction, Gynecologic Cancer, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Atılım UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Floor Muscle Training (PFMT) Group | Active comparator | Other: PFMTTraining will be planned for patients, including strengthening and endurance exercises, |
| PFMT + Aerobic Exercise Group | Experimental | Other: PFMT, Other: Aerobic ExerciseBoth groups will be given PFMT, and the Grup B group will be given aerobic exercise training in addition to PFMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFMTPelvic 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.). | Other | PFMT + Aerobic Exercise Group, Pelvic Floor Muscle Training (PFMT) Group |
| Aerobic ExerciseAerobic 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. | Other | PFMT + Aerobic Exercise Group |
Primary outcome
Pelvic Floor Symptoms
Time frame: change from baseline at 8 weeks
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.
5 secondary outcomes
Pelvic floor muscle strength
Time frame: change from baseline at 8 weeks
Quality of life due to pelvic floor dysfunctions
Time frame: change from baseline at 8 weeks
Cancer-related quality of life
Time frame: change from baseline at 8 weeks
Functional capacity
Time frame: change from baseline at 8 weeks
Fatigue
Time frame: change from baseline at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyda TOPRAK CELENAY, Assoc. Prof. study chair
Ankara Yildirim Beyazıt University
Questions about this trial
What is this clinical trial studying?
A study testing PFMT and Aerobic Exercise in people with Gynecologic Cancer and Pelvic Floor Disorders, run by Atılım University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Büşra BENGÜBOZ (+905074988395, busrabenguboz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Symptoms (time frame: change from baseline at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.