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Pelvic Floor Dysfunction in Pulmonary Systemic Sclerosis

8 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

67

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Turcja (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turcja (Türkiye), 34103
        • Rekrutacyjny
        • Istanbul Faculy of Medicine-Department of Pulmonary Medicine
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Pelvic Floor Dysfunction - Pelvic Floor Distress Inventory-20 Total Score
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Pulmonary Function Test - Forced Expiratory Volume in One Second
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Bioelectrical Impedance Analysis - Muscle Mass
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Biruni University

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 sierpnia 2026

Zakończenie podstawowe (Szacowany)

20 września 2026

Ukończenie studiów (Szacowany)

1 października 2026

Daty rejestracji na studia

Pierwszy przesłany

26 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 września 2026

Pierwszy wysłany (Rzeczywisty)

14 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 12 (Israel lung Association)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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