Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Turkish Validation of the Rapprich Lipedema Symptomatic Assessment Questionnaire (RapprichTR)

21. juli 2026 opdateret af: Marmara University

Turkish Validity and Reliability of the Rapprich Lipedema Symptomatic Assessment Questionnaire

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

180

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: M. Selim Eryılmaz, Res. Asst.

Studiesteder

  • Tyrkiet (Türkiye)
    • Kadıköy
      • Istanbul, Kadıköy, Tyrkiet (Türkiye)
        • Rekruttering
        • Sultan 2. Abdülhamid Han Training and Research Hospital, Physical Medicine and Rehabilitation Clinic, Istanbul, Turkey.
        • Kontakt:
        • Kontakt:
          • İrem Lazkan, Res. Asst.
          • Telefonnummer: +90534 92 63 640
    • Pendik
      • Istanbul, Pendik, Tyrkiet (Türkiye), 34899
        • Rekruttering
        • Marmara University Pendik Training and Research Hospital, Physical Medicine and Rehabilitation Department, Istanbul, Turkey.
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population consists of 180 female patients aged 18 to 75 years diagnosed with Stage I, II, or III lipedema, recruited from the Physical Medicine and Rehabilitation clinics of the participating hospitals.

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Stage I Lipedema
60 female patients diagnosed with Stage I lipedema
Andet: 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

Andet: 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 ankle to calculate the total volume of both lower extremities.
  • 6-Minute Walk Test (6MWT): A functional test to evaluate the total walking distance and heart rate response, assessing the patient's functional capacity.
Stage II Lipedema
60 female patients diagnosed with Stage II lipedema
Andet: 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

Andet: 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 ankle to calculate the total volume of both lower extremities.
  • 6-Minute Walk Test (6MWT): A functional test to evaluate the total walking distance and heart rate response, assessing the patient's functional capacity.
Stage III Lipedema
60 female patients diagnosed with Stage III
Andet: 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

Andet: 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 ankle to calculate the total volume of both lower extremities.
  • 6-Minute Walk Test (6MWT): A functional test to evaluate the total walking distance and heart rate response, assessing the patient's functional capacity.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Internal Consistency (Cronbach's Alpha)
Tidsramme: At baseline (Day 0).
Evaluation of the internal consistency of the 15-item Turkish Rapprich Lipedema Questionnaire.
At baseline (Day 0).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Test-Retest Reliability (ICC)
Tidsramme: Baseline and 14 days
Agreement between two measurements taken 14 days apart in a subgroup of 40 patients.
Baseline and 14 days
Criterion Validity (Correlation with SF-36).
Tidsramme: At baseline (Day 0)
Correlation between Rapprich questionnaire scores and the 8 sub-dimensions of the SF-36 quality of life scale.
At baseline (Day 0)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Marmara University

Efterforskere

  • Ledende efterforsker: Canan Şanal, Assoc. Prof., Marmara University Faculty of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. juli 2026

Primær færdiggørelse (Anslået)

15. februar 2027

Studieafslutning (Anslået)

15. marts 2027

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RapprichTR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner