Меню
Идёт набор NCT07725146

Turkish Validation of the Rapprich Lipedema Symptomatic Assessment Questionnaire

Наблюдательное Lipedema

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Questionnaires, Physical Examination and Functional Testing.
Кому может быть актуально
Состояния в реестре: Lipedema. Базовые параметры: 18 лет — 75 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Turkish Validity and Reliability of the Rapprich Lipedema Symptomatic Assessment Questionnaire

Обзор

Lipedema is a chronic disease characterized by abnormal fat accumulation, primarily in the lower extremities, affecting women. This study aims to evaluate the validity and reliability of the Turkish version of the Rapprich Lipedema Symptomatic Assessment Questionnaire, which was originally developed by Rapprich et al. in 2010. Since a validated Turkish version is currently unavailable, this research will provide a standardized tool for clinicians to assess symptomatic severity in Turkish-speaking lipedema patients.

Подробное описание

This cross-sectional study will involve 180 female participants diagnosed with lipedema (Stages I, II, and III). Participants will be recruited from the Physical Medicine and Rehabilitation clinics of Marmara University and Sultan 2. Abdülhamid Han Training and Research Hospital.

Assessments will include:

* Demographic data (age, BMI). * Physical examinations (waist-hip ratio, limb circumference, and volume calculations). * Functional testing (6-minute walk test). * The Turkish version of the Rapprich Lipedema Symptomatic Assessment -Questionnaire (15 items scored 0-10). * The SF-36 Health Survey for criterion validity.

Statistical analysis will include Cronbach's alpha for internal consistency, Intraclass Correlation Coefficient (ICC) for test-retest reliability (14-day interval), and Exploratory/Confirmatory Factor Analysis for construct validity.

Вмешательства

  • Другое Questionnaires
    Turkish version of Rapprich Lipedema Symptomatic Assessment Questionnaire: A 15-item scale used to evaluate the severity of lipedema symptoms (such as pain, tension, tenderness, bruising, and heaviness) on a 0-10 point rating scale. Short Form-36 (SF-36) Health Survey: A widely used, validated scale to assess the general health status and quality of life across eight sub-dimensions, used in this study for criterion validity
  • Другое Physical Examination and Functional Testing
    * Anthropometric and Vital Measurements: Recording of demographic data (age, height, weight, BMI), as well as arterial blood pressure and pulse rate. * Lipedema-Specific Assessment: Clinical determination of the lipedema stage (Stages I-III) and type (Types I-V). * Morphometric Measurements: Measurement of waist and hip circumferences (for waist-to-hip ratio) and actual leg length. * Lower Extremity Volume Calculation: Circular circumference measurements taken at 4 cm intervals starting from the

Первичные конечные точки

  • Internal Consistency (Cronbach's Alpha) [Срок оценки: At baseline (Day 0).]
Вторичные конечные точки (2)
  • Test-Retest Reliability (ICC) [Срок оценки: Baseline and 14 days]
  • Criterion Validity (Correlation with SF-36). [Срок оценки: At baseline (Day 0)]

Критерии участия

Критерии включения

  • Female patients aged 18-75.
  • Diagnosed with lipedema by a clinician.
  • Willingness to participate and sign the informed consent form.

Критерии исключения

  • Positive Stemmer sign or presence of advanced-stage lymphedema.
  • Diagnosis of Heart Failure.
  • Chronic Kidney Disease.
  • Pregnancy.
  • BMI > 50 kg/m².

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Turkey (Türkiye) · 2 центра
  • Sultan 2. Abdülhamid Han Training and Research Hospital, Physical Medicine and Rehabilitat — Istanbul
  • Marmara University Pendik Training and Research Hospital, Physical Medicine and Rehabilita — Istanbul

Публикации

  • Mortada H, Alhithlool AW, AlBattal NZ, Shetty RK, Al-Mekhlafi GA, Hong JP, Alshomer F. Lipedema: Clinical Features, Diagnosis, and Management. Arch Plast Surg. 2025 May 15;52(3):185-196. doi: 10.1055/a-2530-5875. eCollection 2025 May. PMID 40386000
  • Amato ACM, Amato FCM, Benitti DA, Dos Santos RV. Translation, cultural adaptation, and validation of a lipedema symptoms questionnaire. J Vasc Bras. 2020 Aug 31;19:e20200049. doi: 10.1590/1677-5449.200049. PMID 34178078
  • van la Parra RFD, Deconinck C, Pirson G, Servaes M, Fosseprez P. Lipedema: What we don't know. J Plast Reconstr Aesthet Surg. 2023 Sep;84:302-312. doi: 10.1016/j.bjps.2023.05.056. Epub 2023 May 30. PMID 37390539
  • Rapprich S, Dingler A, Podda M. Liposuction is an effective treatment for lipedema-results of a study with 25 patients. J Dtsch Dermatol Ges. 2011 Jan;9(1):33-40. doi: 10.1111/j.1610-0387.2010.07504.x. Epub 2010 Sep 7. English, German. PMID 21166777

Идентификаторы

NCT: NCT07725146 · RapprichTR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗