Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis
8 сентября 2026 г. обновлено: Biruni University
Association of Pelvic Floor Dysfunction With Pulmonary Function, Respiratory Muscle Strength, and Exercise Capacity in Patients With Systemic Sclerosis With Pulmonary Involvement: A Cross-Sectional Study
Systemic sclerosis (SSc) is a heterogeneous multisystem disease characterized by vascular dysfunction, immune abnormalities, and progressive fibrosis of the skin and internal organs. Pulmonary involvement, particularly interstitial lung disease (ILD), is one of the most common and clinically important manifestations of SSc and may lead to impaired pulmonary function, respiratory muscle weakness, reduced diaphragmatic function, and decreased exercise capacity. In addition to pulmonary involvement, systemic inflammation, physical inactivity, nutritional disturbances, and musculoskeletal manifestations may contribute to generalized skeletal muscle dysfunction in individuals with SSc.
Pelvic floor dysfunction, including urinary and fecal incontinence, pelvic organ prolapse, pelvic pain, and sexual dysfunction, has also been reported in individuals with SSc. Previous studies have suggested that vascular dysfunction, tissue fibrosis, and structural and functional abnormalities of the pelvic floor may contribute to these symptoms. Furthermore, impaired pelvic floor and sexual function in women with SSc have been associated with several disease-related characteristics, including dyspnea, interstitial lung disease, reduced physical activity, functional disability, and impaired quality of life.
The pelvic floor muscles form the inferior component of the core muscle system and function synergistically with the diaphragm and abdominal muscles to regulate intra-abdominal pressure. Coordinated activity between the diaphragm and pelvic floor muscles during respiration has been demonstrated. Therefore, pulmonary and respiratory muscle involvement in SSc may potentially be associated with impaired pelvic floor function. However, the relationships between pelvic floor dysfunction and pulmonary function, respiratory muscle strength, exercise capacity, and core endurance in patients with SSc with pulmonary involvement remain insufficiently understood. Investigating these relationships may contribute to a more comprehensive understanding of pelvic floor dysfunction and its associated factors in this population.
Обзор исследования
Статус
Рекрутинг
Вмешательство/лечение
- Другой: Pelvic Floor Health Knowledge Assessment
- Другой: Pelvic Floor Dysfunction Assessment
- Другой: Core Endurance Assessment
- Другой: Body Composition Assessment
- Другой: Sexual Function Assessment
- Другой: Respiratory Function
- Другой: Functional Exercise Capacity Assessment
- Другой: Functional Status Assessment
Тип исследования
Наблюдательный
Регистрация (Оцененный)
67
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: B.Beril Kılıç
- Номер телефона: 05069496158
- Электронная почта: fztbkilic@gmail.com
Места учебы
-
-
Istanbul
-
Istanbul, Istanbul, Турция (Туркие), 34103
- Рекрутинг
- Istanbul Faculy of Medicine-Department of Pulmonary Medicine
-
Контакт:
- B.Beril Kılıç
- Номер телефона: 05069496158
- Электронная почта: fztbkilic@gmail.com
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
Women aged 18-70 years diagnosed with systemic sclerosis according to the 2013 EULAR/ACR classification criteria and with pulmonary involvement will be recruited from patients referred from the Department of Pulmonary Medicine, Istanbul Faculty of Medicine.
Participants will undergo assessment of pelvic floor dysfunction and related pulmonary and functional parameters.
Описание
Inclusion Criteria:
- Meeting the 2013 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria for systemic sclerosis (SSc),
- Having pulmonary involvement,
- Being a woman aged 18-70 years
Exclusion Criteria:
- Having a severe chronic comorbid condition,
- Having any other rheumatologic disease,
- Having hearing or visual impairments,
- Having a concomitant neurological, cardiovascular, or orthopedic disorder.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pelvic Floor Dysfunction - Pelvic Floor Distress Inventory-20 Total Score
Временное ограничение: Baseline
|
A 20-item questionnaire assessing pelvic floor symptoms across three subscales: POPDI-6, UDI-6, and CRADI-8 will be used.
The total score ranges from 0 to 300, with higher scores indicating greater symptom-related distress and worse pelvic floor health.
The Turkish validity and reliability were established.
|
Baseline
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pulmonary Function Test - Forced Expiratory Volume in One Second
Временное ограничение: Baseline
|
Pulmonary function will be assessed using a spirometry system (ZAN 300 MGA) in accordance with American Thoracic Society (ATS) acceptability criteria.
Forced expiratory volume in one second (FEV₁) will be recorded and reported as percent predicted (%).
|
Baseline
|
|
Pulmonary Function Test - Forced Vital Capacity
Временное ограничение: Baseline
|
Pulmonary function will be assessed using a spirometry system (ZAN 300 MGA) in accordance with American Thoracic Society (ATS) acceptability criteria.
Forced vital capacity (FVC) will be recorded as a measure of pulmonary function and reported as percent predicted (%).
|
Baseline
|
|
Pulmonary Function Test - Diffusing Capacity of the Lungs for Carbon Monoxide
Временное ограничение: Baseline
|
Diffusing capacity of the lungs for carbon monoxide (DLCO) will be assessed using the ZAN 300 MGA system in accordance with standardized testing procedures and reported as percent predicted (%).
|
Baseline
|
|
Maximum Inspriratory Pressure
Временное ограничение: Baseline
|
Maximum Inspiratory Pressure (MIP): Inspiratory muscle strength will be assessed using a portable electronic respiratory pressure meter (MicroRPM; Micro Medical, UK) in accordance with ATS/ERS guidelines.
MIP will be measured during a maximal inspiratory effort (Müller maneuver) with the nose occluded.
At least three measurements will be performed with a minimum 1-minute rest between trials.
MIP will be reported in cmH₂O, with higher absolute values indicating greater inspiratory muscle strength.
|
Baseline
|
|
Maximum Expiratory Pressure
Временное ограничение: Baseline
|
Maximum Expiratory Pressure (MEP): Expiratory muscle strength will be assessed using a portable electronic respiratory pressure meter (MicroRPM; Micro Medical, UK) in accordance with ATS/ERS guidelines.
Participants will perform a maximal expiratory effort with the nose occluded.
At least three measurements will be performed, with a minimum 1-minute rest between trials, and the highest valid value will be recorded.
MEP will be reported in cmH₂O, with higher values indicating greater expiratory muscle strength.
|
Baseline
|
|
Functional Exercise Capacity - 6-Minute Walk Test
Временное ограничение: Baseline
|
Functional exercise capacity will be assessed using the Six-Minute Walk Test (6MWT) in accordance with ATS guidelines.
Participants will be instructed to walk as far as possible at their own pace along a 30-meter flat corridor for six minutes.
A 10-minute seated rest period will be provided before the test.
Resting during the test will be permitted without stopping the timer.
The total distance walked in six minutes will be recorded in meters (m), with a greater distance indicating better functional exercise capacity.
|
Baseline
|
|
Trunk Flexor Endurance - McGill Core Endurance Test
Временное ограничение: Baseline
|
Trunk flexor endurance will be assessed using the McGill Core Endurance Test.
Participants will maintain a standardized position with the knees flexed to 90° and the trunk at 60°, with the arms crossed over the chest.
The duration for which the position can be maintained will be recorded in seconds (s), with a longer duration indicating greater trunk flexor endurance.
|
Baseline
|
|
Trunk Extensor Endurance - McGill Core Endurance Test
Временное ограничение: Baseline
|
Trunk extensor endurance will be assessed using the McGill Core Endurance Test.
Participants will maintain the trunk horizontally unsupported in the prone position while the lower body is stabilized.
The test will end when the participant is unable to maintain the required position.
The duration will be recorded in seconds (s), with a longer duration indicating greater trunk extensor endurance.
|
Baseline
|
|
Lateral Trunk Endurance - McGill Core Endurance Test
Временное ограничение: Baseline
|
Lateral trunk endurance will be assessed using a modified side-bridge test with the knees flexed.
Participants will support the body on the lower elbow and knees and maintain the required position for as long as possible.
The test will end when the participant is unable to maintain the position.
The duration will be recorded in seconds (s), with a longer duration indicating greater lateral trunk endurance.
|
Baseline
|
|
Cough-Related Quality of Life - Leicester Cough Questionnaire
Временное ограничение: Baseline
|
Leicester Cough Questionnaire (LCQ): The impact of cough on health-related quality of life will be assessed using the Leicester Cough Questionnaire (LCQ), a 19-item questionnaire comprising physical, psychological, and social domains.
The total score ranges from 3 to 21, with higher scores indicating better cough-related quality of life and a better outcome.
The Turkish version of the LCQ has been demonstrated to be valid and reliable.
|
Baseline
|
|
Modified Medical Research Council Dyspnea Scale
Временное ограничение: Baseline
|
Modified Medical Research Council (mMRC) Dyspnea Scale: Dyspnea during activities of daily living will be assessed using the modified Medical Research Council (mMRC) Dyspnea Scale.
The scale ranges from 0 to 4, with higher scores indicating greater dyspnea severity and a worse outcome.
|
Baseline
|
|
Sexual Function - Arizona Sexual Experiences Scale
Временное ограничение: Baseline
|
Sexual function will be assessed using the Arizona Sexual Experiences Scale (ASEX), a 5-item scale evaluating sexual drive, arousal, physiological arousal, ability to reach orgasm, and satisfaction from orgasm.
The total score ranges from 5 to 30, with higher scores indicating greater sexual dysfunction and a worse outcome.
A total score of ≥19, a score of 5 or 6 on any single item, or a score of ≥4 on three or more items indicates sexual dysfunction.
The Turkish version of the ASEX has been demonstrated to be valid and reliable.
|
Baseline
|
|
Disease-Related Functional Status - Scleroderma Health Assessment Questionnaire
Временное ограничение: Baseline
|
Functional status and limitations in activities of daily living will be assessed using the Scleroderma Health Assessment Questionnaire (SHAQ).
The questionnaire evaluates disability and disease-related limitations associated with systemic sclerosis, including Raynaud's phenomenon, digital ulcers, pulmonary symptoms, gastrointestinal symptoms, and overall disease severity.
Higher scores indicate greater disability and a worse functional outcome.
|
Baseline
|
|
Pelvic Floor Health Knowledge - Pelvic Floor Health Knowledge Test
Временное ограничение: Baseline
|
Pelvic floor health knowledge will be assessed using the Pelvic Floor Health Knowledge Quiz (PFHKQ), a 29-item questionnaire evaluating knowledge of pelvic floor function and dysfunction, risk and etiology, and diagnosis and treatment.
Each correct response is scored as 1 and incorrect or "I don't know" responses as 0, resulting in a total score ranging from 0 to 29.
Higher scores indicate greater pelvic floor health knowledge and a better outcome.
|
Baseline
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Bioelectrical Impedance Analysis - Muscle Mass
Временное ограничение: Baseline
|
Muscle mass will be assessed by bioelectrical impedance analysis using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions.
Muscle mass will be recorded in kilograms (kg).
|
Baseline
|
|
Bioelectrical Impedance Analysis - Body Mass Index
Временное ограничение: Baseline
|
Body Mass Index (BMI): Body mass index (BMI) will be calculated using measured body weight and height as weight in kilograms divided by height in meters squared (kg/m²).
BMI will be reported in kg/m².
|
Baseline
|
|
Bioelectrical Impedance Analysis - Body Weight
Временное ограничение: Baseline
|
Body weight will be measured using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions.
Participants will be assessed barefoot and wearing light clothing.
Body weight will be recorded in kilograms (kg).
|
Baseline
|
|
Bioelectrical Impedance Analysis - Body Fat Mass
Временное ограничение: Baseline
|
Body fat mass will be assessed by bioelectrical impedance analysis using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions.
Body fat mass will be recorded in kilograms (kg).
|
Baseline
|
|
Bioelectrical Impedance Analysis - Body Fat Percentage
Временное ограничение: Baseline
|
Body fat percentage will be assessed by bioelectrical impedance analysis using the Tanita BC-730 InnerScan Body Composition Monitor under standardized measurement conditions.
Body fat percentage will be recorded as a percentage (%).
|
Baseline
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- McGill SM, Childs A, Liebenson C. Endurance times for low back stabilization exercises: clinical targets for testing and training from a normal database. Arch Phys Med Rehabil. 1999 Aug;80(8):941-4. doi: 10.1016/s0003-9993(99)90087-4.
- Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. doi: 10.1067/mob.2001.118659.
- Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.
- Zachovajeviene B, Siupsinskas L, Zachovajevas P, Venclovas Z, Milonas D. Effect of diaphragm and abdominal muscle training on pelvic floor strength and endurance: results of a prospective randomized trial. Sci Rep. 2019 Dec 16;9(1):19192. doi: 10.1038/s41598-019-55724-4.
- Yakut H, Yalcinkaya G, Ozyurek S, Ozalevli S, Salik Sengul Y, Birlik M. Assessment of diaphragmatic function by ultrasonography in patients with systemic sclerosis and its relation to clinical parameters : A case-control study. Wien Klin Wochenschr. 2023 Oct;135(19-20):528-537. doi: 10.1007/s00508-023-02163-x. Epub 2023 Apr 3.
- Walterspacher S, Schlager D, Walker DJ, Muller-Quernheim J, Windisch W, Kabitz HJ. Respiratory muscle function in interstitial lung disease. Eur Respir J. 2013 Jul;42(1):211-9. doi: 10.1183/09031936.00109512. Epub 2012 Dec 20.
- Umar SB, Griffing L, Garcia H, Foxx-Orenstein AE, DiBaise JK, Crowell MD. The Impact of Pelvic Floor and Lower Gastrointestinal Symptoms on Quality of Life in Women With Systemic Sclerosis. J Clin Gastroenterol. 2016 Jul;50(6):e55-9. doi: 10.1097/MCG.0000000000000405.
- Hermankova B, Spiritovic M, Oreska S, Storkanova H, Mann H, Pavelka K, Senolt L, Vencovsky J, Becvar R, Tomcik M. Effect of an 8-Week Tailored Physiotherapy Program on Sexual Health in Women with Scleroderma and Myositis: A Controlled Pilot Study. Rheumatol Ther. 2023 Aug;10(4):1089-1105. doi: 10.1007/s40744-023-00559-9. Epub 2023 May 23.
- Hermankova B, Spiritovic M, Smucrova H, Oreska S, Storkanova H, Komarc M, Pavelka K, Senolt L, Vencovsky J, Becvar R, Tomcik M. Female Sexual Dysfunction and Pelvic Floor Muscle Function Associated with Systemic Sclerosis: A Cross-Sectional Study. Int J Environ Res Public Health. 2022 Jan 5;19(1):612. doi: 10.3390/ijerph19010612.
- Dogan H, Altuntas Yilmaz N. Pelvic floor dysfunction symptoms and knowledge level and quality of life in systemic sclerosis women. Women Health. 2025 Sep;65(8):675-683. doi: 10.1080/03630242.2025.2557943. Epub 2025 Sep 9.
- American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
- Alkotob ML, Soltani P, Sheatt MA, Katsetos MC, Rothfield N, Hager WD, Foley RJ, Silverman DI. Reduced exercise capacity and stress-induced pulmonary hypertension in patients with scleroderma. Chest. 2006 Jul;130(1):176-81. doi: 10.1378/chest.130.1.176.
- Al'deges, W. A., & Çelenay, Ş. T. (2021). Development of pelvic floor health knowledge quiz in Turkish people: validity and reliability. Türk Fizyoterapi ve Rehabilitasyon Dergisi, 32(2), 122-131.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 августа 2026 г.
Первичное завершение (Оцененный)
20 сентября 2026 г.
Завершение исследования (Оцененный)
1 октября 2026 г.
Даты регистрации исследования
Первый отправленный
26 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
8 сентября 2026 г.
Первый опубликованный (Действительный)
14 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 сентября 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 12 (Israel lung Association)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .